ObesityNCT06619041
HealthyTogether: RCT of a Dyadic Weight Management Intervention
A study testing HealthyTogether in people with Obesity and Overweight, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- HealthyTogether
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran participants:
- 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
- Able to participate in virtual intervention sessions during regular business hours
Show all 10Show fewer
- Partner participants:
- Able to participate in virtual intervention sessions during regular business hours
- Speak with Veteran at last weekly
- Live in the same state where Veteran receives VA care
Who cannot join
- Veterans are excluded if:
- 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
- have a history of (within past 2 years) or plans to (within next 6 months) have bariatric surgery
Show all 24Show fewer
- are pregnant, postpartum, nursing, or planning to become pregnant within 6 months
- are receiving cancer (non-skin) treatment
- have drug or alcohol dependence not in remission, a recent suicide attempt, active psychosis, or an active behavior flag in the medical record
- report high-levels of alcohol use (AUDIT-C score >=8)
- are receiving hospice or palliative care
- are living in a nursing home or assisted living facility
- are enrolled in VA home-based primary care
- have end stage renal disease
- have a current or past diagnosis of anorexia or bulimia
- have had an inpatient hospitalization in the past 3 months
- weigh more than 440 pounds (this is the upper limit of the study's scales)
- Partners are excluded if:
- not fluent in English
- have severe hearing loss prohibiting participation
- endorse having a health condition that may limit their ability to participate in the intervention
- report high-levels of current alcohol use (AUDIT-C score >=8)
- are receiving hospice or palliative care
- are living in a nursing home or assisted living facility
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Luis M Perez, PhD RD, (720) 467-0757, luis.perez2@va.gov
Briana Robustelli, (720) 723-6872, Briana.Robustelli@va.gov
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Jennifer L Jay, (206) 277-1417, jennifer.jay663@va.gov
Steven B Zeliadt, PhD MPH, (206) 277-4175, Steven.Zeliadt@va.gov
About this study
Official title: Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether
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.
Read the 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 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:
- Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans (primary).
- Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes, including health behaviors (i.e., diet, physical activity) and relationship quality.
- Examine Veteran and partner contributions to changes in their own and each other's outcomes using dyadic analyses, informing potential future intervention targets.
- 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.
- Conditions
- Obesity, Overweight
- Being tested
- HealthyTogether
- Keywords
- Weight Loss, Weight Loss Programs, Social Support, Diet, Physical Activity, Virtual Medicine, Family, Dyadic
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyTogetherBehavioural
HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Receives the brief, virtual, dyadic HealthyTogether weight management intervention in addition to usual care. Receives: Behavioral: HealthyTogether |
| Usual Care Arm | No intervention | Receives a brief letter with information about weight management and couples/family resources in addition to usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Secondary outcomes (9)
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).
Measured: 6-months
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.
Measured: 6-months
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.
Measured: 12-months
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.
Measured: 6-months
Change in self-reported diet quality from Baseline to 6-months among partners
This outcome is measured by self-report using the eight-item Starting the Conversation measure.
Measured: 6-months
Change in physical activity from Baseline to 6-months among Veterans
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
Measured: 6-months
Change in physical activity from Baseline to 6-months among partners
This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.
Measured: 6-months
Change in relationship quality from Baseline to 6 months among Veterans
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
Measured: 6-months
Change in relationship quality from Baseline to 6 months among partners
This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start14 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Brief, virtual, dyadic weight management intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kristen E. Gray, PhD MS BS, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619041
- Sponsor's protocol ID
- IIR 23-040
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Such requests will be evaluated in terms of protecting potential intellectual property value and rights of VA and its employees, collaborators and research sponsors, and any other proprietary or security concerns, including protection of Personal Identifiable Information (PII) and Protected Health Information (PHI), terms of Confidentiality Agreements or other such restrictions and protections.
Publications
Gray KE, Benson S, Robustelli BL, Perez L, Taylor L, Nelson KM, Hoerster KD. Protocol for HealthyTogether: A randomized controlled trial testing a virtual, dyadic weight management intervention for a veteran and a support person. Contemp Clin Trials. 2026 Jun;165:108309. doi: 10.1016/j.cct.2026.108309. Epub 2026 Apr 13.
PubMed 41985657
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether
- ClinicalTrials.gov ID
- NCT06619041
- Acronym / sponsor ID
- IIR 23-040
- Conditions
- Obesity, Overweight
- Keywords
- Weight Loss, Weight Loss Programs, Social Support, Diet, Physical Activity, Virtual Medicine, Family, Dyadic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans (primary).
- Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes, including health behaviors (i.e., diet, physical activity) and relationship quality.
- Examine Veteran and partner contributions to changes in their own and each other's outcomes using dyadic analyses, informing potential future intervention targets.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Brief, virtual, dyadic weight management intervention
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Behavioral: HealthyTogetherReceives the brief, virtual, dyadic HealthyTogether weight management intervention in addition to usual care. |
| Usual Care Arm | No intervention | –Receives a brief letter with information about weight management and couples/family resources in addition to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Able to participate in virtual intervention sessions during regular business hours
Key exclusion criteria (24 listed)
- 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
- have a history of (within past 2 years) or plans to (within next 6 months) have bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyTogetherHealthyTogether is a brief (8-session), virtual, dyadic weight management intervention. | Behavioural | Treatment Arm |
Primary outcome
Change in weight from Baseline to 6-months among Veterans
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.
9 secondary outcomes
Change in weight from Baseline to 6-months among Veterans (using EHR-data)
Time frame: 6-months
Change in weight from Baseline to 6-months among partners
Time frame: 6-months
Change in weight from Baseline to 12-months among Veterans (using EHR data)
Time frame: 12-months
Change in self-reported diet quality from Baseline to 6-months among Veterans
Time frame: 6-months
Change in self-reported diet quality from Baseline to 6-months among partners
Time frame: 6-months
Change in physical activity from Baseline to 6-months among Veterans
Time frame: 6-months
Change in physical activity from Baseline to 6-months among partners
Time frame: 6-months
Change in relationship quality from Baseline to 6 months among Veterans
Time frame: 6-months
Change in relationship quality from Baseline to 6 months among partners
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publication: PubMed 41985657Gray KE, Benson S, Robustelli BL, Perez L, Taylor L, Nelson KM, Hoerster KD. Protocol for HealthyTogether: A randomized controlled trial testing a virtual, dyadic weight management intervention for a veteran and a support person. Contemp Clin Trials. 2026 Jun;165:108309. doi: 10.1016/j.cct.2026.108309. Epub 2026 Apr 13.
- Individual participant dataSharing planned: No. Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Such requests will be evaluated in terms of protecting potential intellectual property value and rights of VA and its employees, collaborators and research sponsors, and any other proprietary or security concerns, including protection of Personal Identifiable Information (PII) and Protected Health Information (PHI), terms of Confidentiality Agreements or other such restrictions and protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen E. Gray, PhD MS BS principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyTogether in people with Obesity and Overweight, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen E Gray, PhD MS BS ((206) 764-2056, Kristen.Gray2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from Baseline to 6-months among Veterans (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.