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Coached or Non-Coached Weight Loss Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04645108
Enrollment
246
Registered
2020-11-27
Start date
2020-11-20
Completion date
2021-06-10
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Eating, Behavior, Health, Obesity, Overweight and Obesity, Self Efficacy, Weight Loss

Brief summary

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.

Interventions

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

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.

BEHAVIORALNoom Healthy Weight; mobile behavior change program for weight loss

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.

Sponsors

Noom Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight4 monthsSelf reported
Self reported in app engagement measures4 monthsself reported and automatically logged

Secondary

MeasureTime frameDescription
Resilience via Devereux Adult Resilience Survey4 monthsProvides insights into personal strengths
Quality of Life Via SF-124 monthsSelf-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure
Linguistic Features via Linguistic Inquiry Word Count (LIWC)16 weeksLIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt
Self Efficacy via General Self-Efficacy Scale4 monthsThe 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.
Eating Behavior via the Dutch Eating Behavior Questionnaire4 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026