Incentivizing Behavior Change Skills to Promote Weight Loss

NCT ID: NCT02691260

Last Updated: 2019-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no incentives

Participants do not receive financial incentives.

Group Type NO_INTERVENTION

No interventions assigned to this group

incentives for dietary self-monitoring

Participants receive financial incentives for dietary self-monitoring.

Group Type ACTIVE_COMPARATOR

incentives for dietary self-monitoring

Intervention Type BEHAVIORAL

Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.

incentives for interim weight loss

Participants receive financial incentives for interim weight loss.

Group Type ACTIVE_COMPARATOR

incentives for interim weight loss

Intervention Type BEHAVIORAL

Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.

incentives for both

Participants receive incentives for dietary self-monitoring and interim weight loss.

Group Type EXPERIMENTAL

incentives for both

Intervention Type BEHAVIORAL

Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

incentives for dietary self-monitoring

Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.

Intervention Type BEHAVIORAL

incentives for interim weight loss

Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.

Intervention Type BEHAVIORAL

incentives for both

Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* desire to lose weight;
* agree to attend visits per protocol;
* access to telephone and transportation;
* English speaking;
* able to complete study measures;
* smart phone with data and texting plan;
* body mass index 30 kg/m2 or greater

Exclusion Criteria

* pregnancy, breastfeeding, or lack of birth control if premenopausal
* dementia, excessive alcohol use, or psychiatric illness
* weight loss \>4.5 kg in month prior to screening
* weight \> 380 lb (due to limit of cellular scale)
* enrollment in other weight loss program
* residing in nursing home or receiving home health care
* unable to attend weight loss group at scheduled times
* impaired hearing
* medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
* unstable heart disease in 3 months prior to screening
* furosemide 40 mg or higher (or equivalent)
* chronic kidney disease
* 2 or more errors on cognitive screener
* blood pressure ≥160/100 mmHg
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan J Shaw, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Voils CI, Levine E, Gierisch JM, Pendergast J, Hale SL, McVay MA, Reed SD, Yancy WS Jr, Bennett G, Strawbridge EM, White AC, Shaw RJ. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2018 Feb;65:116-122. doi: 10.1016/j.cct.2017.12.007. Epub 2017 Dec 28.

Reference Type RESULT
PMID: 29289702 (View on PubMed)

Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.

Reference Type DERIVED
PMID: 37546286 (View on PubMed)

Voils CI, Pendergast J, Hale SL, Gierisch JM, Strawbridge EM, Levine E, McVay MA, Reed SD, Yancy WS, Shaw RJ. A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity. Transl Behav Med. 2021 Apr 26;11(4):954-969. doi: 10.1093/tbm/ibaa102.

Reference Type DERIVED
PMID: 33245118 (View on PubMed)

Shaw R, Levine E, Streicher M, Strawbridge E, Gierisch J, Pendergast J, Hale S, Reed S, McVay M, Simmons D, Yancy W, Bennett G, Voils C. Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11972. doi: 10.2196/11972.

Reference Type DERIVED
PMID: 30758297 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R34HL125669-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00056410

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personalizing Financial Incentives
NCT07225426 NOT_YET_RECRUITING NA
Supporting Decisions on Lifestyle Change
NCT06206954 ENROLLING_BY_INVITATION NA