Feasibility Study for Collaborate2Lose

September 15, 2023 updated by: University of Wisconsin, Madison

Feasibility Study for Collaborate2Lose: Collaborating With Support Persons to Improve Long-term Weight Loss

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (Veteran):

  1. Aged 18 years or older
  2. BMI ≥ 30 kg/m2
  3. Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
  4. Weight ≤ 420lbs due to limit of the study scales
  5. 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
  6. Desire to lose weight
  7. Ability to speak English
  8. Agrees to attend visits per protocol
  9. Score of at least 4 out of 6 on a validated cognitive screener
  10. Access to hardware and internet connection to enable participation with approved virtual platform
  11. Individual email address
  12. Able to stand on a scale without assistance

Exclusion Criteria (Veteran):

  1. Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
  2. Active dementia, psychiatric illness, or substance abuse
  3. History of bariatric surgery
  4. 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.
  5. Chronic kidney disease at stage 4 or higher
  6. Participation in MOVE! in the past 3 months
  7. Currently enrolled in a research or clinical program focusing on lifestyle change
  8. Pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
  9. Psychiatric illness not well-controlled by medication or therapy
  10. Score ≥ 8 on alcohol abuse screener
  11. Use of any drugs not prescribed, excluding cannabis
  12. Weight loss ≥ 10lb in the month prior to screening
  13. Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
  14. Is unable to control what food is prepared and/or served in household
  15. Problems with hearing that prevent attendance to a virtual class and talking on the telephone
  16. Currently enrolled in a research or clinical program focusing on lifestyle change
  17. History of bariatric surgery (reconfirm) or planning to have bariatric surgery in the next 18 months
  18. Current use of weight loss medications
  19. Worsening heart failure requiring medication dose change in the past 6 months
  20. Hospitalization for heart problems in the past 6 months
  21. Current treatment or treatment in the past 6 months for cancer (besides non-melanoma skin cancers)
  22. Dizziness or lightheadedness at rest or associated with physical activity
  23. Chest pain in the past 6 months

Inclusion Criteria (support person):

  1. Aged 18 years or older
  2. Willing to participate
  3. Score of at least 4 out of 6 on a validated cognitive screener
  4. Ability to speak English

Exclusion Criteria (support person):

  1. Underweight (BMI < 18.5 kg/m2)
  2. Active dementia, uncontrolled psychiatric illness, or substance abuse
  3. Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
  4. Problems with hearing that prevent attendance to a virtual class and talking on the telephone
  5. Any severe health issue that would impair the partner's ability to provide support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Partner-Supported
Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention.
Behavioral: Partner support
Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Screening to enrollment ratio
Time Frame: baseline
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
Time Frame: 16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 16 weeks
Weight at 16 weeks is the primary endpoint. Veterans will be asked to weigh themselves during a virtual study visit, on a study-provided scale, while wearing light clothing (i.e., no outerwear such as jackets), with shoes removed.
16 weeks
Intervention adherence
Time Frame: 14 weeks
Intervention adherence is calculated as the average number of group sessions attended by index participants.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
William S. Middleton Memorial Veterans Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Corrine Voils, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-0629
  • SMPH/SURGERY/WISOR (Other Identifier: UW Madison)
  • Protocol Version 1/24/23 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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