HealthyTogether
BehavioralHealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.
NCT Number: NCT06619041
Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE! Weight Management Program. Family and friends strongly influence a person's 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 14-week, 8-session virtual weight management program that includes Veterans and a support person (e.g., 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States
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 3.2 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 (e.g., 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 14 weeks, individual dyads receive 8 hour-long video sessions with a clinician. 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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Veteran participants:
Partner participants:
Exclusion criteria
Veterans are excluded if:
Partners are excluded if:
HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.
Time frame: 6-months
Weight is measured using a study-provided scale during a scheduled virtual study visit. Veterans will either (1) display the weight on the scale to study staff or (2) take a picture of the weight on the scale with a digital device and show the weight to study staff. For weight measurements at both timepoints, we will instruct participants to weigh themselves in light clothing and no shoes, with the scale on a hard, flat surface. We will record date and time of weight assessments and will make every attempt to collect follow-up weights at a similar time of day as baseline.
Time frame: 6-months
We will collect supplementary EHR-based weights from for all Veteran participants. We will use the EHR weight closest to 182 days +/- 60 days post-baseline. While the primary outcome is limited to Veterans with study team measured weight, secondary analyses will be conducted among all participants with available weight outcomes (staff verified and/or EHR-based).
Time frame: 6-months
Weight is measured using a study-provided scale during a scheduled virtual study visit. Partners will either (1) display the weight on the scale to study staff or (2) take a picture of the weight on the scale with a digital device and show the weight to study staff. We will record date and time of weight assessments and will make every attempt to collect follow-up weights at a similar time of day as baseline.
Time frame: 12-months
Baseline weight is measured using a study-provided scale during a scheduled virtual study visit. To examine durability of intervention effects while minimizing participant burden, we will also obtain EHR-based weights at 12 months, using weights collected 365 days +/- 90 days post-baseline among only Veterans.
Time frame: 6-months
This outcome is measured by self-report using the eight-item Starting the Conversation measure.
Time frame: 6-months
This outcome is measured by self-report using the eight-item Starting the Conversation measure.
Time frame: 6-months
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
Time frame: 6-months
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
Time frame: 6-months
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
Time frame: 6-months
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
Contact information is provided by the study sponsor or research team.
Katherine D Hoerster, PhD MPH BA
CONTACT
Kristen E Gray, PhD MS BS
CONTACT
VA Office of Research and Development
Fed
Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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