NCT02957539

Brief Summary

Three of every four Veterans are overweight or obese, and weight loss is associated with reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective but only reaches a small percentage of overweight Veterans. This proposed study will test whether a patient incentive program that gives Veterans non-financial incentives, such as Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective. An effective patient-incentive program could help more Veterans lose weight without requiring a substantial increase in VA staff.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 21, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 31, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

November 1, 2016

Results QC Date

February 28, 2022

Last Update Submit

July 19, 2023

Conditions

Keywords

motivationpatient incentives

Outcome Measures

Primary Outcomes (1)

  • Weight Change From Baseline to Week 32

    The primary outcome is weight measured in pounds at week 32 minus the weight at baseline.

    32 weeks

Secondary Outcomes (11)

  • Self Efficacy

    Change form baseline to 16 weeks

  • Self Efficacy

    Change form baseline to 32 weeks

  • Self Efficacy

    Change form baseline to 52 weeks

  • Intrinsic Motivation

    Change form baseline to 16 weeks

  • Intrinsic Motivation

    Change form baseline to 32 weeks

  • +6 more secondary outcomes

Other Outcomes (1)

  • Total Intervention Costs for All Participants

    through 16 weeks

Study Arms (3)

No Reward

NO INTERVENTION

At enrollment, participants randomized to usual care will be given the MOVE! workbook that serves both as an information resource on diet and exercise, a resource for tools to achieve weight loss goals, and a log of participants' goals, motivations, and outcomes. Each participant will be given a chart with a personalized target weight for a loss of 1lb. per week for 16 weeks. Participants will be given a digital scale or wireless scale and counseled to weigh themselves daily. Participants will enter their weight weekly into an online portal. They will also complete the surveys in the portal. They will receive text message reminders to enter their weight.

Financial Reward Arm

EXPERIMENTAL

Same as usual care, plus financial rewards that are earned in two ways: an assured and random. For the assured reward, they will receive compensation at the end of each month that they are at or below their target weight on the last day of that period. For the random portion, each week that a participant is at or below their target weight, the patient is entered in random drawing to win additional compensation. Over the first eight weeks the patient has a 1-in-8 chance of winning.Over the 17-32 week period, Veterans in this group will receive token rewards for tracking and reporting their weekly weights regardless of whether it was on target. Each week that the patient enters his/her weight into the portal, he will have a 1-in-8 chance to earn the token reward, such as a t-shirt or movie tickets. Participants will enter their weight weekly into an online portal. They will also complete the surveys in the portal. They will receive text message reminders to enter their weight.

Behavioral: Financial rewards

Non-financial Reward Arm

EXPERIMENTAL

Procedures for the non-financial rewards arm is identical to procedures for the financial reward arm, except that the Veteran will earn points rather than cash. Each week a random drawing will be for 20 points, each monthly weigh in is worth 5 points. Veterans will be given non-financial rewards associated with the number of points they earn.

Behavioral: Non-Financial rewards

Interventions

Veterans in the financial reward arm receive all of the services of the usual care arm, plus rewards that are earned in two ways: an assured portion, and a random portion. For the assured reward, they will receive compensation at the end of each month (defined as a four week period) that they are at or below their target weight. For the random portion, each week that a participant is at or below their target weight, the patient is entered into a drawing to win additional compensation. Over the first eight weeks the patient has a 1-in-8 chance of winning. Over the 17-32 week period, Veterans in this group will receive token incentives for tracking and reporting their weekly weights regardless of whether it was on target. Each week that the patient enters their weight into the portal, s/he will have a 1-in-8 chance to earn the token incentive, such as a t-shirt or movie ticket. The participant will receive reminder text messages.

Financial Reward Arm

Procedures for the non-financial rewards arm are identical to procedures for the financial reward arm, except that the Veteran will earn points rather than cash. Each weekly random drawing will be for 20 points. Veterans will choose non-financial rewards associated with the number of points they earn.

Non-financial Reward Arm

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • BMI\>=30 at enrollment
  • weigh less than 390lbs
  • Active patient in primary care or women's clinic (1+ visit in last year)
  • Access to a text capable phone in the Veteran's household or active email address
  • live in Seattle area the entire year
  • access to the internet

You may not qualify if:

  • behavioral flag
  • serious mental illness or anti-psychotic medication
  • eating disorder and/or sexual trauma
  • MOVE! participation in past 4 months
  • pregnant or planning to become pregnant
  • prisoner/employee/student
  • inability to independently stand
  • inability to read
  • insulin dependent
  • impaired decision making
  • no access to a cell phone or phone that can receive text messages
  • inability to remove socks \& shoes
  • \>5% of body weight lost in last 6 months (clinical data and self-report)
  • unable to pass cognitive screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The enrollment goal for the study was 280 participants. Enrollment and study recruitment was terminated on 3/4/2020 with 274 participants due to the COVID-19 pandemic.

Results Point of Contact

Title
Paul Hebert
Organization
VA Puget Sound Health Care System

Study Officials

  • Paul L. Hebert, PhD BA

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 7, 2016

Study Start

March 21, 2018

Primary Completion

March 5, 2021

Study Completion

July 30, 2021

Last Updated

July 28, 2023

Results First Posted

March 31, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

A corresponding data repository has been created for this project. Participants must consent to both the main project and the data repository to be included in both. Otherwise the participant will only be included in this study.

Locations