Clinical trial NCT04586647: Attitudes Toward Food During a Weight Loss Intervention
Official title: Investigation of Healthy Eating Habits and Attitudes Toward Food During a Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Overweight and Obesity
Overweight or Obesity
Eating Behavior
Food Habits
Eating Disorder Symptom
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective randomized, controlled pilot study evaluating relationships towards food in overweight and obese Noom Healthy Weight participants.

Participants will be randomly assigned to one of two conditions (intervention, waitlist control). In the intervention condition, participants will have immediate access to the full Noom program after consenting to Noom's Research Policy, which states the collection of in app user data for research purposes. In the waitlist control condition, participants will be informed that they are on a waiting list and will be provided access to the full Noom program after 4 months after consenting to Noom's Research Policy.

Noom will have access to participants' username and email address. Before the start of the program, participants in both conditions will be emailed a survey containing the validated questionnaires mentioned below. The survey will also ask for demographic information such as race, ethnicity, and socioeconomic status. Survey responses will be linked to weight data by email address, but all data will be de-identified prior to analysis. The same survey, without demographic questions, will be sent to participants again at program end (4 months).

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.

The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a 4 month weight loss intervention (Noom Healthy Weight program).

Secondary outcomes assessing disordered eating habits and mindfulness will be measured via the Disordered Eating Attitude Questionnaire and the Mindful Eating Scale. Mean weight loss differences between groups will also be measured.

Eligibility criteria: Inclusion Criteria:

* Able to understand and provide informed consent
* 18 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.

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., eating disorders

Primary outcomes:
measure: Self-reported eating behaviors via the Three Factor Eating Questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: Self reported disordered eating habits via the Disordered Eating Attitude Questionnaire
timeFrame: 4 months
measure: Self reported mindful eating habits via the Mindful Eating Scale
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Noom, Inc.
state: New York
Study officials:
References: