Attitudes Toward Food During a Weight Loss Intervention

NCT04586647 | Completed

• 1 other identifier: 00046455
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the Noom Healthy Weight Program, a digital behavior change weight loss intervention, creates a positive relationship with food, compared to a waitlist control group.

Conditions

Obesity; Weight Loss; Overweight and Obesity; Overweight or Obesity; Eating Behavior; Food Habits; Eating Disorder Symptom

Outcome Measures

Primary Outcomes (1)

• Self-reported eating behaviors via the Three Factor Eating Questionnaire

  The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a weight loss intervention This assessment is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I - 20 items), disinhibition (Factor II - 16 items), and hunger (Factor III - 15 items). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Part I includes items 1-36 and are rated either 1-True or 0-False. Part II includes items 37-51 and is rated on a 4-point scale with the exception of item 50, which is rated on a 6-point scale. Higher scores reflective of higher restraint,

  4 months

Secondary Outcomes (2)

• Self reported disordered eating habits via the Disordered Eating Attitude Questionnaire

  4 months

• Self reported mindful eating habits via the Mindful Eating Scale

  4 months

Study Arms (2)

Noom Health Weight Program

EXPERIMENTAL

Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.

Wait List Control

NO INTERVENTION

Interventions

Noom Healthy Weight; mobile behavior change program for weight loss. BEHAVIORAL

The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach. Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.

Noom Health Weight Program

Eligibility Criteria

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

You may qualify if:

• Able to understand and provide informed consent
• years and older
• Self-report of good health
• Not diagnosed with an eating disorder
• Overweight or obesity (BMI ≥ 25)
• Able to meet our criteria of adherence to the program (at least 1 engagement per week on
• one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
• Not 6 months postpartum
• Not planning to become pregnant in the next 5 months.

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent
• Currently pregnant or 6 months postpartum
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data
• E.g., eating disorders

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Noom, Inc.

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Overweight; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

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 7, 2020
• First Posted: October 14, 2020
• Study Start: November 4, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 30, 2021
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)