Clinical trial NCT02691260: Incentivizing Behavior Change Skills to Promote Weight Loss
Official title: Incentivizing Behavior Change Skills to Promote Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
behavioral intervention
diet
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-02-25
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Change From Baseline to 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Ryan J Shaw, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.