Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

NCT05015491 | Completed

• 1 other identifier: Noom 2021-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.

Conditions

NASH; Fatty Liver; NAFLD; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in BMI

  BMI

  baseline to day 112

Secondary Outcomes (4)

• Fibroscan

  Baseline to day 112

• Fibroscan - from baseline to day 112

  Baseline to day 112

• Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score

  Baseline to day 168

• Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).

  Baseline to day 168

Study Arms (1)

Noom Healthy Weight Program

EXPERIMENTAL

The Noom platform uses a cognitive behavioral approach to weight loss that integrates set content with interaction with live coaches to support client efforts at behavior change. The Healthy Weight program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults". It has 52 weeks of curriculum with 1-3 articles to read per day (Reading level: Grade 6-8).

Behavioral: Noom Healthy Weight Program

Interventions

Noom Healthy Weight Program BEHAVIORAL

The Healthy Weight program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults". Users are encouraged to log their weight (Weight Logging) at least 1x/week and log their food and beverages (Food Logging) daily. Exercise logging (steps via automatic collection or manually added) is done daily. The Noom Food color grading system is founded on calorie-density (Volumetrics diet, Barbara Rolls) and is a simple and effective method for creating long lasting changes in diet and food choice. Coaches are contacted via In-app messaging or phone communication.

Noom Healthy Weight Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>18 years of age, inclusive, at Day -7.
• BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -7.
• Has no plan to change smoking habits during the study period.
• Has ability to access study related online programs and apps.
• Willing to follow study instructions, as well as complete online questionnaires.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.

You may not qualify if:

• Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
• Self-reported type 1 diabetes.
• History of gastrointestinal surgery for weight reducing purposes.
• Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -7.
• Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
• Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
• Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
• Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -7.
• Exposure to any non-registered drug product within 30 d of Day -7.
• Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or
• ½ oz distilled spirits).
• ALT or AST \> 5 x ULN at baseline.

Sponsors & Collaborators

• Noom Inc.: lead
• Arizona Liver Health: collaborator

Study Sites (1)

Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Weight Loss

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: August 9, 2021
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)