Coached or Non-Coached Weight Loss Intervention

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching
* Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coached<br> | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching<br>* 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.<br>|
| Active Comparator: No Coach<br> | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Self reported | 4 months | 
| Self reported in app engagement measures | self reported and automatically logged | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Via SF-12 | 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 | 4 months | 
| Eating Behavior via the Dutch Eating Behavior Questionnaire | 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. | 4 months | 
| Resilience via Devereux Adult Resilience Survey | Provides insights into personal strengths | 4 months | 
| Self Efficacy via General Self-Efficacy Scale | 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. | 4 months | 
| Linguistic Features via Linguistic Inquiry Word Count (LIWC) | LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt | 16 weeks |