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OpenTrials
Completed

NCT Number: NCT04645108

Coached or Non-Coached Weight Loss Intervention

To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.

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Key information

Conditions

Obesity Behavior Behavior, Animal Behavior, Eating Behavior, Health Body Weight Body Weight Changes Feeding Behavior Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Self Efficacy Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noom, Inc

New York, 10001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and provide informed consent
  • 18-65 years old
  • Self-report of good health (physical and mental)
  • Not diagnosed with diabetes
  • Overweight or obesity (BMI ≥ 27)
  • 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.

Exclusion criteria

  • 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., evidence of an eating disorder, major chronic condition

Treatment and study plan

Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching

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 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. During the first week of the study, participants will be introduced to the program, and the Noom app.

Primary outcomes

  1. Weight

    Time frame: 4 months

    Self reported

  2. Self reported in app engagement measures

    Time frame: 4 months

    self reported and automatically logged

Secondary outcomes

  1. Quality of Life Via SF-12

    Time frame: 4 months

    Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure

  2. Eating Behavior via the Dutch Eating Behavior Questionnaire

    Time frame: 4 months

    The Dutch Eating Behavior Questionnaire (DEBQ) assesses the structure of an individual's eating behavior. the DEBQ contains separate scales for emotional, external, and restrained eating behavior.

  3. Resilience via Devereux Adult Resilience Survey

    Time frame: 4 months

    Provides insights into personal strengths

  4. Self Efficacy via General Self-Efficacy Scale

    Time frame: 4 months

    The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.

  5. Linguistic Features via Linguistic Inquiry Word Count (LIWC)

    Time frame: 16 weeks

    LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt

Sponsors and collaborators

Lead sponsor

Noom Inc.

Industry

Registry information

Official study title

Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2020
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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