NCT05646771

Brief Summary

In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

December 2, 2022

Last Update Submit

September 15, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Screening to enrollment ratio

    We will calculate the screening to enrollment ratio. Our feasibility metric is 2:1 (i.e., 2 people start the phone screening in order to have one provide consent).

    baseline

  • Retention Rate for primary outcome

    The outcome assessment retention rate at 16 weeks will be calculated as \[#of index participants who provide a weight at 16 weeks/number who provided a baseline weight\]. Our metric is at least 80% retention at 16 weeks.

    16 weeks

Secondary Outcomes (2)

  • Weight

    16 weeks

  • Intervention adherence

    14 weeks

Study Arms (1)

Partner-Supported

EXPERIMENTAL

Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention.

Behavioral: Partner support

Interventions

Partner supportBEHAVIORAL

Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)

Partner-Supported

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • BMI ≥ 30 kg/m2
  • Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
  • Weight ≤ 420lbs due to limit of the study scales
  • Cohabitating and daily contact for at least the past 6 months with an adult who can provide support (e.g. spouse/domestic partner, sibling, friend, family member) during the study period
  • Desire to lose weight
  • Ability to speak English
  • Agrees to attend visits per protocol
  • Score of at least 4 out of 6 on a validated cognitive screener
  • Access to hardware and internet connection to enable participation with approved virtual platform
  • Individual email address
  • Able to stand on a scale without assistance

You may not qualify if:

  • Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
  • Active dementia, psychiatric illness, or substance abuse
  • History of bariatric surgery
  • Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, Torsemide 20 mg daily, Bumetanide 1 mg daily or any use of Metolazone). Use of potassium-sparing diuretics is acceptable.
  • Chronic kidney disease at stage 4 or higher
  • Participation in MOVE! in the past 3 months
  • Currently enrolled in a research or clinical program focusing on lifestyle change
  • Pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
  • Psychiatric illness not well-controlled by medication or therapy
  • Score ≥ 8 on alcohol abuse screener
  • Use of any drugs not prescribed, excluding cannabis
  • Weight loss ≥ 10lb in the month prior to screening
  • Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
  • Is unable to control what food is prepared and/or served in household
  • Problems with hearing that prevent attendance to a virtual class and talking on the telephone
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Corrine Voils, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

March 13, 2023

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)