Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss

NCT06666842 | Completed

• 1 other identifier: 00064357
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial (RCT) will test how well a fully remote weight management program (Noom Weight) helps adults with overweight or obesity (BMI 25-45) achieve weight loss in both the short-term (16 weeks) and the long-term (68 weeks), compared to an educational program). Participants will be randomly assigned to use the 16-week Noom Weight program or receive weekly emails with weight loss-related tips and information. Weight will be measured at baseline, 16, 29, 42, and 68 weeks. Changes in physical activity, eating disorder risk, and body appreciation will also be assessed.

Conditions

Obesity; Weight Loss

Keywords

Obesity; Weight Loss; Weight Maintenance; Digital Health; Mobile App

Outcome Measures

Primary Outcomes (1)

• Percent weight change at Week 16

  Body weight will be measured using self-report and cellular-connected digital scales (Body Trace). The digital scale is linked to participant IDs and synced to record weigh-ins automatically. If a participant does not report a weight or the reported weight appears to be erroneous, then the raw scale data will be used.

  Baseline, Week 16

Secondary Outcomes (6)

• Percent weight change at Week 29

  Baseline, Week 29

• Percent weight change at Week 42

  Baseline, Week 42

• Percent weight change at Week 68

  Baseline, Week 68

• Physical activity change at Week 68

  Baseline, Week 68

• Changes in eating disorder risk at Week 68

  Baseline, Week 68

Study Arms (2)

Noom Weight

EXPERIMENTAL

Participate in a 16-week fully remote digital weight management program focusing on weight loss and management via behavioral change

Behavioral: Noom Weight

Educational Control

ACTIVE COMPARATOR

Receive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines

Behavioral: Educational Control

Interventions

Noom Weight BEHAVIORAL

Participants assigned to Noom Weight will be provided access to the app-based program for 16 weeks. This program offers access to self-monitoring features, psychoeducational articles, one-on-one coaching from health experts, and group support. The app includes a robust database of foods, allowing users to track their energy intake. Self-monitoring via the app enables users to review and monitor behavior and weight change patterns. Daily articles review principles of behavior change, nutrition, exercise, etc.

Noom Weight

Educational Control BEHAVIORAL

Participants assigned to the educational control will receive 16 brief (5-10 minute read) weekly newsletters outlining information on developing and maintaining a healthy diet and lifestyle adapted from the 2015-2020 Department of Health and Human Services (HHS) and Department of Agriculture (USDA) Dietary Guidelines for Americans. Newsletters include detailed information on topics such as nutrition fundamentals (e.g., calorie limits; healthy eating), food groups and dietary guidelines (e.g., importance of vegetables, fruits, and grains), and tips for habit change (e.g., reducing added sugar and saturated fats). Each week includes prompts for individuals to try new strategies (e.g., make a conscious decision about everything you eat; try to eat at your calorie budget).

Educational Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old
• Self-reported body mass index (BMI) of 25-45
• Proficient in English
• Live in the United States
• Have access to an iOS smartphone or tablet and were willing to use applications daily
• Willing to abstain from engaging in other weight loss programs for 16 weeks
• Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by a physician (except for multivitamins or other vitamin supplements)
• Have a goal of losing weight
• Complete a decisional balance exercise based on the work of Goldberg and Kiernan (2005). During this exercise, participants reviewed the nature, design, and importance of this study and were prompted to consider the pros and cons of participation. The purpose of this exercise was to ensure that participants fully understood and were willing to participate in the study, as well as to increase study retention.

You may not qualify if:

• Weight loss of ≥ 5 kg within the past 6 months
• History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within the past 6 months
• Major surgery interfering with consuming a regular diet and performing physical activity within the past 6 months
• Hospitalized for psychiatric problems within the past 12 months
• Paid subscription to Noom within the past 12 months
• Concurrent enrollment in other weight management programs or clinical trials that may interfere
• Living with another study participant
• Ever been diagnosed with an eating disorder
• Diagnosis of conditions indicative of weight loss difficulties or unsupervised exercise as being unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
• History of chronic/inflammatory gastrointestinal disorder, with the expectation of irritable bowel syndrome
• Diagnosis of diabetes
• Previous surgical procedure for weight loss
• Presence of implanted cardiac defibrillator or pacemaker
• Current, recent, or planned pregnancy in the next 12 months
• Cancer within past 5 years

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Noom Inc.

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body 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

Model Details: Participants will be randomized to one of two conditions in a parallel design with assessments occurring before randomization (Baseline) and at 16, 29, 42, and 68 weeks.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)