A Mobile Health and Wellness Coaching Intervention for Weight Loss

Study Overview
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Brief Summary
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The objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mHWC) intervention, as compared to usual care (UC), for weight loss in adults. Participants were randomly assigned to one of the two groups (mHWC or UC). At the beginning of the study, both groups were given a Fitbit wearable device, and a weight scale. All participants also received a counseling session from a dietician focused on diet, physical activity, and sleep, and were set up on the Nudge app, a commercially-available mHWC platform. Participants in the mHWC group received text-based coaching messages via Nudge and did not return to the clinic for the duration of the 6-month intervention. Those in the UC group met once a month with a pharmacist or dietician for 6 months. In both groups, the focus was on facilitating health behavior change related to diet, physical activity, and sleep to promote weight loss. We hypothesized that weight loss at 6 months would be greater in the mHWC group vs. the UC group.

Official Title
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Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss

Conditions
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Overweight and Obesity, Health Behavior

Intervention / Treatment
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* Behavioral: mobile Health and Wellness Coaching
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥27 kg/m^2 Waist circumference ≥35 inches (women) or ≥40 inches (men) Own an Android smartphone or iPhone capable of running the Nudge and Fitbit applications. Indicate sending at least one text-based (e.g., SMS, Facebook, Twitter) message via their smartphone on most days Exclusion Criteria: Pregnant Pacemaker or other electronic implant Weight ≥400 pounds Weight loss ≥5% of bodyweight in previous 6 months High cardiovascular risk, as determined by Physical Activity Readiness Questionnaire (PAR-Q) and physician review, as needed.

Ages Eligible for Study
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Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile Health and Wellness Coaching<br> | Behavioral: mobile Health and Wellness Coaching<br>* Participants in the mobile health and wellness coaching (mHWC) group received text-based mHWC messages and did not return to the clinic until the end of the 6 month intervention. Messages were sent at least weekly and focused on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. Participants could respond via text at any time. The Nudge platform was used for all messaging.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* Participants in the usual care (UC) group met in-person once a month with either a pharmacist or dietician for the duration of the 6-month intervention. The focus of these sessions was on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. These participants were set up on the Nudge app, but they did not use the mHWC (texting) feature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Assessed at baseline and follow-up | 6 months (mean 193 ± 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Waist Circumference | Assessed at baseline and follow-up | 6 months (mean 193 ± 21 days) | 
| Change in Self-Reported Physical Activity | Assessed via Exercise Vital Sign (EVS) at baseline and follow-up. The EVS is used to assess via self-report the amount of physical activity or exercise an individual engages in during an average week. It asks: 1. On average, how many days a week do you perform physical activity or exercise, such as walking or jogging? and 2. On average, how many minutes of physical activity or exercise do you perform on those days? | 6 months (mean 193 ± 21 days) | 
| Change in Self-Reported Sleep Quantity | Assessed via Pittsburgh Sleep Quality Index (PSQI) at baseline and follow-up. The PSQI is used to assess via self-report an individual's nightly average sleep quality and quantity over the previous 30 day period. As for quality, the higher the score, the lower the quality of sleep. | 6 months (mean 193 ± 21 days) | 
| Change in Self-Reported Daily Caloric Consumption | Assessed via the Automated Self-Assessment 24-hour (ASA24) Dietary Assessment at baseline and follow-up. The ASA24 is a detailed 24-hour food recall that can be used to estimate via self-report diet quality and quantity. | 6 months (mean 193 ± 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health and Wellness Coaching