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Incentivizing Behavior Change Skills to Promote Weight Loss

Incentivizing Behavior Change Skills to Promote Weight Loss

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02691260
Enrollment
105
Registered
2016-02-25
Start date
2016-04-30
Completion date
2018-05-31
Last updated
2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, behavioral intervention, diet

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.

Interventions

BEHAVIORALincentives for dietary self-monitoring

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

BEHAVIORALincentives for interim weight loss

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

BEHAVIORALincentives 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight Change From Baseline to 24 Weeks24 weeksMeasured in pounds

Countries

United States

Participant flow

Participants by arm

ArmCount
no Incentives
Participants do not receive financial incentives.
26
Incentives for Dietary Self-monitoring
Participants receive financial incentives for dietary self-monitoring. incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
26
Incentives for Interim Weight Loss
Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
27
Incentives for Both
Participants receive incentives for dietary self-monitoring and interim weight loss. 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.
26
Total105

Baseline characteristics

CharacteristicIncentives for Dietary Self-monitoringno IncentivesIncentives for Interim Weight LossIncentives for BothTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants4 Participants1 Participants2 Participants13 Participants
Age, Categorical
Between 18 and 65 years
20 Participants22 Participants26 Participants24 Participants92 Participants
Age, Continuous51.27 years
STANDARD_DEVIATION 15.46
49.65 years
STANDARD_DEVIATION 12.73
46.44 years
STANDARD_DEVIATION 11.15
45.92 years
STANDARD_DEVIATION 12.84
48.3 years
STANDARD_DEVIATION 13.12
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants26 Participants27 Participants23 Participants102 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
6 Participants7 Participants12 Participants8 Participants33 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants2 Participants1 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
19 Participants15 Participants13 Participants17 Participants64 Participants
Region of Enrollment
United States
26 Participants26 Participants27 Participants26 Participants105 Participants
Sex: Female, Male
Female
24 Participants22 Participants21 Participants25 Participants92 Participants
Sex: Female, Male
Male
2 Participants4 Participants6 Participants1 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 260 / 270 / 26
other
Total, other adverse events
3 / 263 / 265 / 271 / 26
serious
Total, serious adverse events
1 / 260 / 260 / 270 / 26

Outcome results

Primary

Weight Change From Baseline to 24 Weeks

Measured in pounds

Time frame: 24 weeks

ArmMeasureValue (MEAN)Dispersion
no IncentivesWeight Change From Baseline to 24 Weeks-8.046 Pounds (lbs.)Standard Deviation 13.316
Incentives for Dietary Self-monitoringWeight Change From Baseline to 24 Weeks-15.496 Pounds (lbs.)Standard Deviation 15.391
Incentives for Interim Weight LossWeight Change From Baseline to 24 Weeks-12.167 Pounds (lbs.)Standard Deviation 17.884
Incentives for BothWeight Change From Baseline to 24 Weeks-17.696 Pounds (lbs.)Standard Deviation 10.312

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026