Noom Coach for Bariatric Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-14

Study Completion Date

2021-09-07

Brief Summary

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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.

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Detailed Description

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Overweight and obesity have reached epidemic proportions in the United States. As few behavioral treatments are effective for weight loss, bariatric surgery is an increasingly important option. Although these procedures are more helpful than psychosocial treatments, post-operative weight losses vary widely, and a notable subset of patients demonstrate suboptimal weight loss or substantial weight regain. Adherence to treatment recommendations is a likely contributor to these variable outcomes. Smartphone applications (apps) designed to augment behavior change or enhance adherence, have expanded exponentially in recent years, and are a potentially useful option to improve outcomes, but rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. This study will test a combined smartphone app and health coaching system to improve adherence and behavioral/psychosocial outcomes for patients receiving bariatric surgery. The aims have not been modified since the original phase 1 and will compare usual pre-operative care and pre-surgical use of Noom Coach for Bariatric Health on post-surgery adherence and psychosocial variables in a larger test (n=200) to explore whether usage of the app is a viable predictor of subsequent post-operative weight trajectories 12 months following surgery. This study will also examine app usage as a viable predictor of subsequent post-operative weight and psychosocial trajectories in the 12 months post-surgery and establish sensitivity and specificity of early optimal response to surgical intervention using weight loss, diet and exercise adherence, and psychosocial adjustment.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Two successive randomizations based on patterned response to primary intervention. Pre-surgical participants (n=200) will be randomized to groups in Noom Coach for Bariatric Health or standard care pre-surgery. Post-surgery, optimal and suboptimal responders will be randomized to Noom Bariatric or standard care. This design allows for comparisons between all 8 conditions. Contrasts allow us to answer the critical question about main effects of Noom Pre-surgery and Noom augmentation and whether this augmentation effect differs based on empirically derived classification of early response.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A. Presurgery Noom Bariatric + Augmentation Noom Bariatric

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.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

B. Presurgery Noom Bariatric + Augmentation Standard Care

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 "usual care" in which participants are free to seek any assistance for their bariatric post-surgery care during the study period.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

C. Presurgery Noom Bariatric + Augmentation Noom Bariatric

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 non-responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

D. Presurgery Noom Bariatric + Augmentation Standard Care

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 non-responsive individuals will be randomized post-surgery to "usual care" in which participants are free to seek any assistance for their bariatric post-surgery care during the study period.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

E. Pre-surgery Standard Care + Augmentation Noom Bariatric

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. Usual care responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

F. Pre-surgery Standard Care + Augmentation Standard Care

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. Usual care responsive individuals will be randomized post-surgery to usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

G. Pre-surgery Standard Care + Augmentation Noom Bariatric

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. Usual care non-responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.

Group Type EXPERIMENTAL

Noom Coach for Bariatric Health

Intervention Type BEHAVIORAL

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 pre and or post-surgery.

H. Pre-surgery Standard Care + Augmentation Standard Care

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. Usual care non-responsive individuals will be randomized post-surgery to usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Noom Coach for Bariatric Health

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 pre and or post-surgery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in: (1) the Metabolic, Endocrine, and Minimally Invasive Surgery Division at Mount Sinai and planning to receive a bariatric procedure.
* Between the ages of 18 and 60 at entry to the study.
* Speak English.

Exclusion Criteria

* Clinically significant cognitive limitations (Wechsler Abbreviated Scale of Intelligence IQ Estimate \< 70) or history of developmental disability.
* History of neurological disorder or injury (e.g., seizure disorder or moderate or severe head injury with \>10 minutes loss of consciousness).
* Current/lifetime DSM-5 bipolar disorder, schizophrenia, or psychotic disorder.
* Acute suicide risk.
* Current DSM-5 alcohol or substance use disorder.
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No