NCT03386006

Brief Summary

The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2017

Shorter than P25 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

October 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

October 30, 2017

Last Update Submit

May 19, 2023

Conditions

Obesity

Keywords

bariatric surgerymobile health (mHealth)psychosocial functioningobesityweight lossbehavioral activation

Outcome Measures

Primary Outcomes (3)

  • 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 and 8 weeks

  • 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.

    Ongoing

  • 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 and 8 weeks

Secondary Outcomes (3)

  • Eating Disorder Examination Questionnaire (EDE-Q)

    Baseline and 8 weeks

  • Depression Anxiety Stress Scales (DASS)

    Baseline and 8 weeks

  • Short Form-36 Health Survey (SF-36)

    Baseline and 8 weeks

Study Arms (2)

Noom Coach for Bariatric Health

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.

Behavioral: Noom Coach for Bariatric Health

Usual Care

NO INTERVENTION

The control group will be a "usual care" condition in which participants are free to seek any assistance for their bariatric surgery care during the study period.

Interventions

Noom Coach for Bariatric HealthBEHAVIORAL

Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks.

Noom Coach for Bariatric Health

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
  • Between the ages of 18 and 60 at entry to the study.
  • Speak English.

You may not qualify if:

  • Clinically significant cognitive limitations or history of developmental disability.
  • History of neurological disorder or injury.
  • Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
  • Acute suicide risk.
  • Current DSM-5 alcohol or substance use disorder.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noom, Inc.

New York, New York, 10001-5915, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

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

Study Record Dates

First Submitted

October 30, 2017

First Posted

December 29, 2017

Study Start

December 5, 2017

Primary Completion

November 9, 2018

Study Completion

November 9, 2018

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)