Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619041
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
HealthyTogether RCT of a Dyadic Weight Management Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Harnessing the Power of Social Support for Weight Management a Randomized Controlled Trial of HealthyTogether
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Four in five Veterans have overweight or obesity However few eligible Veterans achieve meaningful weight loss in VAs national MOVE Weight Management Program Family and friends strongly influence a persons health behaviors and weight Including a close family member or friend in weight management may improve weight management outcomes This study will test whether an 8-week virtual weight management program that includes Veterans and a support person eg family member or friend leads to weight loss The investigators will also test whether the program leads to improvements in weight-related health behaviors including physical activity and diet and relationship quality
Detailed Description:
The prevalence of overweight and obesity is more than 80 among VA users increasing risk of morbidity and mortality In 2006 VA nationally implemented the MOVE Weight Management Program an evidence-based behavioral weight management program Effectiveness of MOVE is suboptimal 20 of all participants and only 30 of those with intense and sustained participation achieve clinically meaningful weight loss Furthermore only 8-9 of eligible Veterans attend any MOVE sessions and among those who do half attend only a single session Taken together 2 of the 32 million eligible Veterans lose clinically meaningful weight in MOVE Therefore additional weight management approaches are needed to address obesity at the VA population-level
One strategy to improve behavioral weight management effectiveness is by leveraging social relationships Social support improves weight management program initiation retention and short and long-term weight loss and is also a major driver of weight-related behaviors such as physical activity and diet quality However social relationships can also impede weight management for example when close others eg family and friends undermine or do not support behavior change The key to addressing this double-edged sword of social relationships may be through dyadic approaches that include close others in behavioral weight management with a focus on improving communication and relationship quality
HealthyTogether is a brief virtual weight management program for Veterans and a close other partner Over 8 weeks individual dyads receive six hour-long and two 30-minute video sessions Session content includes physical activity diet and weight management medication education goal setting and relationship and communication skills training and practice informed by evidence-based dyadic treatments This study is a two-site hybrid type I effectiveness-implementation randomized controlled trial with a primary focus on evaluating effectiveness of HealthyTogether and a secondary focus on understanding determinants of implementation The aims of the trial are
1 Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans primary
2 Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes including health behaviors ie diet physical activity and relationship quality
3 Examine Veteran and partner contributions to changes in their own and each others outcomes using dyadic analyses informing potential future intervention targets
4 Assess determinants of implementation including cost feasibility acceptability and appropriateness guided by the Consolidated Framework for Implementation Research to inform future implementation
Considering the burden of overweight and obesity in VA and the limited reach and effectiveness of MOVE HealthyTogether has the potential to address multiple VA priorities mitigate obesity-related chronic disease and involve family in Veterans care Study findings will inform VA National Center Health for Health Promotion and Disease Prevention efforts to expand effective evidence-based weight management services for Veterans
One strategy to improve behavioral weight management effectiveness is by leveraging social relationships Social support improves weight management program initiation retention and short and long-term weight loss and is also a major driver of weight-related behaviors such as physical activity and diet quality However social relationships can also impede weight management for example when close others eg family and friends undermine or do not support behavior change The key to addressing this double-edged sword of social relationships may be through dyadic approaches that include close others in behavioral weight management with a focus on improving communication and relationship quality
HealthyTogether is a brief virtual weight management program for Veterans and a close other partner Over 8 weeks individual dyads receive six hour-long and two 30-minute video sessions Session content includes physical activity diet and weight management medication education goal setting and relationship and communication skills training and practice informed by evidence-based dyadic treatments This study is a two-site hybrid type I effectiveness-implementation randomized controlled trial with a primary focus on evaluating effectiveness of HealthyTogether and a secondary focus on understanding determinants of implementation The aims of the trial are
1 Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans primary
2 Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes including health behaviors ie diet physical activity and relationship quality
3 Examine Veteran and partner contributions to changes in their own and each others outcomes using dyadic analyses informing potential future intervention targets
4 Assess determinants of implementation including cost feasibility acceptability and appropriateness guided by the Consolidated Framework for Implementation Research to inform future implementation
Considering the burden of overweight and obesity in VA and the limited reach and effectiveness of MOVE HealthyTogether has the potential to address multiple VA priorities mitigate obesity-related chronic disease and involve family in Veterans care Study findings will inform VA National Center Health for Health Promotion and Disease Prevention efforts to expand effective evidence-based weight management services for Veterans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None