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

NCT ID: NCT05015491

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2022-09-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Noom Healthy Weight Program

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).

Group Type: EXPERIMENTAL

Noom Healthy Weight Program

Intervention Type: 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.

Interventions

Noom Healthy Weight Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

1½ oz distilled spirits).

• ALT or AST > 5 x ULN at baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona Liver Health

UNKNOWN

Sponsor Role: collaborator

Noom Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Liver Health

Chandler, Arizona, United States

Countries

United States

Other Identifiers

Noom 2021-01

Identifier Type: -

Identifier Source: org_study_id