Brief Summary

Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. As more Americans consider bariatric surgery for the treatment of severe obesity, it is imperative to improve factors influencing suboptimal surgical outcomes (e.g., failure to adhere to diet and exercise recommendations and psychosocial impairment). This study will evaluate the effect of the Noom Coach for Bariatric Health platform in improving standard interventions utilized in bariatric surgery programs.

Trial Health

On Track

Trial Health Score

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

Enrollment

200

participants targeted

Target at P75+ for not_applicable obesity

Timeline

Completed

Started Sep 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

3 years study duration

Study Start

First participant enrolled

September 14, 2018

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed

Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

March 17, 2019

Last Update Submit

May 19, 2023

Conditions

Obesity

Keywords

ObesityBariatric SurgerymHealth

Outcome Measures

Primary Outcomes (5)

Change in adherence to dietary recommendations
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Baseline, 8 weeks, 3 months, and 12 months
Change in adherence to physical activity recommendations (Activity Tracker)
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Baseline, 8 weeks, 3 months, and 12 months
Change in adherence to physical activity recommendations (IPAQ)
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
Baseline, 8 weeks, 3, 6, 9, and 12 months
Anthropometric changes (weight)
To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.
Baseline, 8 weeks, 3, 6, and 12 months
Anthropometric changes (height)
To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.
Baseline, 8 weeks, 3, 6, and 12 months

Secondary Outcomes (3)

Eating Disorder Examination Questionnaire (EDE-Q)
Baseline, 8 weeks, 3, 6, 9, and 12 months
Depression Anxiety Stress Scales (DASS)
Baseline, 8 weeks, 3, 6, 9, and 12 months
Short Form-36 Health Survey (SF-36)
Baseline, 8 weeks, 3, 6, 9, and 12 months

Study Arms (8)

A. Presurgery Noom Bariatric + Augmentation Noom Bariatric

EXPERIMENTAL

Self-monitoring will be conducted through Noom Coach for Bariatric Health, and individuals will receive a specialized set of instructions on how to use the app. Intervention responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.