Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-09 @ 6:57 AM
Study NCT ID:
NCT03661918
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHAT at HOME Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'This study is a 2 x 2 x 2 randomized clinical trial. In addition to the 10 core coaching sessions, there will be three additional components available to participants, depending on the experimental condition to which they are randomized. These potential additional components include 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Data', 'timeFrame': '4 months', 'description': 'Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.'}], 'secondaryOutcomes': [{'measure': 'Child BMI', 'timeFrame': '4 months', 'description': 'Track and measure child BMI percentiles at beginning and end of study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parent, adolescent, coaching, weight loss'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': 'This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.', 'detailedDescription': "All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parent/primary caregiver of child in the 8-12 year old age range based on child birth date\n* The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards\n* Child lives with parent/primary caregiver 50% of the time\n* Willing to have a second caregiver participate in this study\n* Wifi at home\n* The parent and child can speak, read, and understand English\n\nExclusion Criteria:\n\n* Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,\n* Chromosomal abnormality such as Down's syndrome or Turner's syndrome\n* Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)\n* Child enrolled in a different weight management program\n* Family participating in any other child research study related to dietary intake, physical activity, weight\n* Plans to move more than 50 miles from your present location within the next 6 months"}, 'identificationModule': {'nctId': 'NCT03661918', 'briefTitle': 'CHAT at HOME Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Changing Habits Together at Home Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY00004193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'In-person first session, no second caregiver, no wifi-enabled scale', 'interventionNames': ['Behavioral: In-Person First Session']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'In-person first session, no second caregiver, wifi-enabled scale', 'interventionNames': ['Behavioral: In-Person First Session', 'Behavioral: WiFi-enabled Scale']}, {'type': 'OTHER', 'label': 'Group 3', 'description': 'In-person first session, second caregiver, no wifi-enabled scale', 'interventionNames': ['Behavioral: In-Person First Session', 'Behavioral: Second Caregiver']}, {'type': 'OTHER', 'label': 'Group 4', 'description': 'In-person first session, second caregiver, wifi-enabled scale', 'interventionNames': ['Behavioral: In-Person First Session', 'Behavioral: Second Caregiver', 'Behavioral: WiFi-enabled Scale']}, {'type': 'OTHER', 'label': 'Group 5', 'description': 'No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only', 'interventionNames': ['Behavioral: 10 Core Coaching Calls Only']}, {'type': 'OTHER', 'label': 'Group 6', 'description': 'No in-person first session, no second caregiver, wifi-enabled scale', 'interventionNames': ['Behavioral: WiFi-enabled Scale']}, {'type': 'OTHER', 'label': 'Group 7', 'description': 'No in-person first session, second caregiver, no wifi-enabled scale', 'interventionNames': ['Behavioral: Second Caregiver']}, {'type': 'OTHER', 'label': 'Group 8', 'description': 'No in-person first session, second caregiver, wifi-enabled scale', 'interventionNames': ['Behavioral: Second Caregiver', 'Behavioral: WiFi-enabled Scale']}], 'interventions': [{'name': 'In-Person First Session', 'type': 'BEHAVIORAL', 'description': 'Conduct first session in person vs. over the phone', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Second Caregiver', 'type': 'BEHAVIORAL', 'description': 'Have second caregiver participate in three coaching calls', 'armGroupLabels': ['Group 3', 'Group 4', 'Group 7', 'Group 8']}, {'name': 'WiFi-enabled Scale', 'type': 'BEHAVIORAL', 'description': 'Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale', 'armGroupLabels': ['Group 2', 'Group 4', 'Group 6', 'Group 8']}, {'name': '10 Core Coaching Calls Only', 'type': 'BEHAVIORAL', 'description': 'Participant will receive 10 core phone coaching sessions', 'armGroupLabels': ['Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Nancy Sherwood, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}