Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-01 @ 10:40 AM
Study NCT ID:
NCT04490356
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Physical Function in the Long-term for Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathryn.starr@duke.edu', 'phone': '919-660-7571', 'title': 'Kathryn Starr, Ph.D.', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to COVID restrictions, the research team had to minimize the number of in-person visits. Consequently, outcome measures data was only collected for baseline (0 weeks) and at 12 weeks.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week endpoint', 'description': 'Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'PRIMARY', 'title': 'Acceptability as Measured by Participant Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 week endpoint', 'description': 'Participants will asked to rate their satisfaction by answering the question "Overall, I\'m glad I participated in this weight maintenance program" with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study; data were not collected for one participant who completed.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Performance as Measured by the Short Physical Performance Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '11.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Scores range from 0 to 12 with higher score indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study; data were not collected for one participant who completed.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Function as Measured Using the 6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)'}, {'title': '12 weeks'}], 'timeFrame': '0 weeks, 12 weeks', 'description': 'Change in distance walked in six minutes from baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to safety concerns during the COVID pandemic, the 6 Minute Walk Test was not administered to participants at all, so data from the 6 Minute Walk Test were not collected.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight as Measured by the Aria Fitbit Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '216.1', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '215.4', 'spread': '27.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Body weight in pounds.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study; data were not collected for one participant who completed.'}, {'type': 'SECONDARY', 'title': 'Change in Average Weekly Steps Measured Using Garmin Watch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '6204.8', 'spread': '3802.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '6365.0', 'spread': '4109.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Average step counts using Garmin watch.', 'unitOfMeasure': 'steps per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study; data were not collected for one participant who completed.'}, {'type': 'SECONDARY', 'title': 'Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1418.4', 'spread': '364.7', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '1525.8', 'spread': '525.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks,12 weeks', 'description': 'Average total calories consumed.', 'unitOfMeasure': 'calories', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Stress Using the Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '10.8', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '9.0', 'spread': '4.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': 'week 0 (baseline)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '8.8', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Score ranges from 0-60 with higher scores indicating greater depression symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Change in Mood Using the Profile of Mood States Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)'}, {'title': '12 weeks'}], 'timeFrame': '0 weeks, 12 weeks', 'description': 'Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".', 'reportingStatus': 'POSTED', 'populationDescription': 'To reduce participant burden during the COVID pandemic, this questionnaire was not administered to participants at all, so data from the Profile of Mood States (POMS) Questionnaire were not collected.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '75.0', 'spread': '18.7', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '79.2', 'spread': '20.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '59.6', 'spread': '43.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '75.0', 'spread': '39.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '66.7', 'spread': '43.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '64.1', 'spread': '46.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '55.4', 'spread': '21.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '58.1', 'spread': '20.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '78.1', 'spread': '13.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '80.9', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '82.7', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '83.7', 'spread': '28.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '68.5', 'spread': '22.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '75.2', 'spread': '22.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Using the SF-36 Questionnaire - General Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'classes': [{'title': '0 weeks (baseline)', 'categories': [{'measurements': [{'value': '64.6', 'spread': '15.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '63.5', 'spread': '18.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks, 12 weeks', 'description': 'General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.\n\nLegacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-24', 'size': 771849, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-11T14:09', 'hasProtocol': True}, {'date': '2022-05-25', 'size': 159306, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-06T13:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2023-09-15', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2020-07-24', 'resultsFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2020-07-24', 'dispFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-09', 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion Retention', 'timeFrame': '12 week endpoint', 'description': 'Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants'}, {'measure': 'Acceptability as Measured by Participant Satisfaction', 'timeFrame': '12 week endpoint', 'description': 'Participants will asked to rate their satisfaction by answering the question "Overall, I\'m glad I participated in this weight maintenance program" with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Performance as Measured by the Short Physical Performance Battery', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Scores range from 0 to 12 with higher score indicating better performance.'}, {'measure': 'Change in Physical Function as Measured Using the 6 Minute Walk Test', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Change in distance walked in six minutes from baseline'}, {'measure': 'Change in Body Weight as Measured by the Aria Fitbit Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Body weight in pounds.'}, {'measure': 'Change in Average Weekly Steps Measured Using Garmin Watch', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Average step counts using Garmin watch.'}, {'measure': 'Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)', 'timeFrame': '0 weeks,12 weeks', 'description': 'Average total calories consumed.'}, {'measure': 'Change in Stress Using the Perceived Stress Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.'}, {'measure': 'Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Score ranges from 0-60 with higher scores indicating greater depression symptoms.'}, {'measure': 'Change in Mood Using the Profile of Mood States Questionnaire', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning.'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning.'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - Pain Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain.'}, {'measure': 'Quality of Life Using the SF-36 Questionnaire - General Health Scale', 'timeFrame': '0 weeks, 12 weeks', 'description': 'General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss Maintenance']}, 'descriptionModule': {'briefSummary': 'The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters\n* Age ≥ 60\n* Able to speak and understand spoken and written English.\n* Able to record dietary intake and weight\n\nExclusion Criteria:\n\n* Presence of unstable or symptomatic life-threatening illness\n* Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke\n* Inability to complete physical function assessment\n* No access to internet connection to participate in the tele-intervention\n* Unable or unwilling to use provided tablet to participant in tele-intervention\n* History of cognitive impairment"}, 'identificationModule': {'nctId': 'NCT04490356', 'briefTitle': 'Enhancing Physical Function in the Long-term for Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Novel Telehealth Intervention Using Nutrition and Exercise to Extend Intervention Benefits: Enhancing Physical Function in the Long-term for Obese Older Adults', 'orgStudyIdInfo': {'id': 'PRO00105630'}, 'secondaryIdInfos': [{'id': '1P30AG064201-01', 'link': 'https://reporter.nih.gov/quickSearch/1P30AG064201-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Legacy Intervention', 'description': 'Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.', 'interventionNames': ['Behavioral: Legacy Intervention']}], 'interventions': [{'name': 'Legacy Intervention', 'type': 'BEHAVIORAL', 'description': 'The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.', 'armGroupLabels': ['Legacy Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University, School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kathryn Starr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}