Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-08 @ 4:49 AM
Study NCT ID:
NCT03257657
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Helping Moms to be Healthy After Baby
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'darcy.thompson@ucdenver.edu', 'phone': '303 724 7471', 'title': 'Darcy Thompson, Associate Professor', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Once the final participant is recruited', 'description': 'The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group.'}, {'type': 'PRIMARY', 'title': 'Attrition Rate of Subjects Enrolled in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Once the final participant completes the 12 week visit', 'description': 'The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count.'}, {'type': 'PRIMARY', 'title': 'Visit Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'title': 'Attended all 4 visits (Baseline, 4 week visit, 8', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Attended 3 of 4 visits (Baseline, 4 or 8 week visi', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Attended 2 of 4 visits (baseline and 12 week visi', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Attended 0 intervention visits', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Week 12, reported at Week 12', 'description': 'The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either.'}, {'type': 'PRIMARY', 'title': 'Acceptability of a Weight Loss Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Use of Phone Coaching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Investigators will count the total number of times any participant used phone coaching.', 'unitOfMeasure': 'Number of phone coaching sessions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight Between Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks', 'description': 'To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Diet: Intakes Measured in Grams', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'title': 'Saturated fat (g)', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Trans fat (g)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Total sugars (g)', 'categories': [{'measurements': [{'value': '-35.1', 'spread': '50.4', 'groupId': 'OG000'}, {'value': '-25.2', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Added sugars (g)', 'categories': [{'measurements': [{'value': '-25.7', 'spread': '39.5', 'groupId': 'OG000'}, {'value': '-23.3', 'spread': '33.6', 'groupId': 'OG001'}]}]}, {'title': 'protein (g)', 'categories': [{'measurements': [{'value': '-10.2', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'total fat (g)', 'categories': [{'measurements': [{'value': '-9.9', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'carbohydrates (g)', 'categories': [{'measurements': [{'value': '-40.9', 'spread': '79.8', 'groupId': 'OG000'}, {'value': '-46.7', 'spread': '48.8', 'groupId': 'OG001'}]}]}, {'title': 'fiber (g)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing for one Lifestyle Group participant at the 12 week point'}, {'type': 'SECONDARY', 'title': 'Changes in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.5', 'spread': '176', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '126', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.', 'unitOfMeasure': 'MET-h/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Diet and Physical Activity Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'title': 'Physical activity: Sticking to it', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Physical activity: making time for exercise', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Diet', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.\n\nDiet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.\n\nPhysical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.\n\nMaking time scale: -12 to 12; Higher scores indicate improved self-efficacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Motivations to Eat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.\n\nPossible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Readiness to Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'title': 'Losing weight', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Healthy eating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Physical activity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Diet: Intakes Measured in Cups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'title': 'Fruit and fruit juice (cups)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'vegetable intake (cups)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.', 'unitOfMeasure': 'Cups', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing for one Lifestyle Group participant at the 12 week point'}, {'type': 'SECONDARY', 'title': 'Changes in Diet: kCal Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'OG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-294', 'spread': '531.7', 'groupId': 'OG000'}, {'value': '-297', 'spread': '374.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing for one Lifestyle Group participant at the 12 week point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'FG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noted not eligible right after enrolled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.\n\nObservation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.'}, {'id': 'BG001', 'title': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.\n\nLifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'African American, non-Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White, non-Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-08', 'size': 335490, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-31T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2017-08-01', 'resultsFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-06', 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Recruitment', 'timeFrame': 'Once the final participant is recruited', 'description': 'The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment'}, {'measure': 'Attrition Rate of Subjects Enrolled in the Study', 'timeFrame': 'Once the final participant completes the 12 week visit', 'description': 'The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.'}, {'measure': 'Visit Attendance', 'timeFrame': 'Baseline through Week 12, reported at Week 12', 'description': 'The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported'}, {'measure': 'Acceptability of a Weight Loss Intervention', 'timeFrame': '12 weeks', 'description': 'To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.'}, {'measure': 'Evaluation of the Use of Phone Coaching', 'timeFrame': '12 weeks', 'description': 'Investigators will count the total number of times any participant used phone coaching.'}], 'secondaryOutcomes': [{'measure': 'Change in Weight Between Visits', 'timeFrame': 'Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks', 'description': 'To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.'}, {'measure': 'Changes in Diet: Intakes Measured in Grams', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.'}, {'measure': 'Changes in Physical Activity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.'}, {'measure': 'Changes in Diet and Physical Activity Self-efficacy', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.\n\nDiet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.\n\nPhysical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.\n\nMaking time scale: -12 to 12; Higher scores indicate improved self-efficacy.'}, {'measure': 'Changes in Motivations to Eat', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.\n\nPossible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.'}, {'measure': 'Changes in Readiness to Change', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change'}, {'measure': 'Changes in Diet: Intakes Measured in Cups', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.'}, {'measure': 'Changes in Diet: kCal Intake', 'timeFrame': 'Baseline and 12 weeks', 'description': 'To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss', 'Diet Modification', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:\n\nAim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.\n\nAim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.', 'detailedDescription': 'Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.\n\nObesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult woman (≥18 and \\<50 years old).\n* Enrolled in WIC or with an infant enrolled in WIC.\n* 3-12 months postpartum.\n* A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).\n* Postpartum body mass index between 25 and 50 kg/m2.\n* English- and/or Spanish-speaking.\n* Owns a mobile phone with texting functionality in order to receive texts during the trial.\n\nExclusion Criteria:\n\n* Health conditions impacting weight or ability to participate in a weight loss trial.\n* Pregnancy or planned pregnancy in next 5 months.\n* Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.\n* Medical provider recommendation to avoid exercise.\n* Plans to be in a different geographic area within the next 5 months.\n* Plans to stop coming to Aurora WIC in the next 5 months.\n* Unable to give informed consent.\n* Not able to read and understand English or Spanish at an 8th grade level.\n* Not willing to create a Facebook account if they do not already have one.\n* Asked to follow-up in \\< 3 months at most recent WIC visit.'}, 'identificationModule': {'nctId': 'NCT03257657', 'briefTitle': 'Helping Moms to be Healthy After Baby', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Helping Moms to be Healthy After Baby', 'orgStudyIdInfo': {'id': '16-1932'}, 'secondaryIdInfos': [{'id': 'UL1TR002535', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002535', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observational Group', 'description': 'Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.', 'interventionNames': ['Behavioral: Observation Group participants']}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle Group', 'description': 'Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.\n\nIn-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.', 'interventionNames': ['Behavioral: Lifestyle group participants']}], 'interventions': [{'name': 'Observation Group participants', 'type': 'BEHAVIORAL', 'description': 'Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.', 'armGroupLabels': ['Observational Group']}, {'name': 'Lifestyle group participants', 'type': 'BEHAVIORAL', 'description': 'Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.', 'armGroupLabels': ['Lifestyle Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80011', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora WIC Office', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Darcy A Thompson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colorado Clinical & Translational Sciences Institute', 'class': 'OTHER'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}