Health Trials

HealthyTogether: RCT of a Dyadic Weight Management Intervention

ConditionsObesityOverweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Assigned to a VA primary care provider

Have a weight measurement (BMI>=30) recorded in the VA medical record within 16 weeks prior to enrollment

Have a second, valid weight measurement recorded in the VA medical record within the prior year

Have a BMI>=30 at enrollment

Disqualifiers

not fluent in English

have severe hearing loss prohibiting participation

have a dementia diagnosis

have recently (within the past 3 months) participated in a clinical or research behavioral weight management program

Trial design

Design model

Parallel

Treatments tested in this trial

  • HealthyTogether

    Behavioral

    HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Usual Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in weight from Baseline to 6-months among Veterans

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

Secondary outcomes

1

Change in weight from Baseline to 6-months among Veterans (using EHR-data)

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
2

Change in weight from Baseline to 6-months among partners

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
6-months
3

Change in weight from Baseline to 12-months among Veterans (using EHR data)

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
12-months
4

Change in self-reported diet quality from Baseline to 6-months among Veterans

This outcome is measured by self-report using the eight-item Starting the Conversation measure.

Time frame
6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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