A Mobile Health and Wellness Coaching Intervention for Weight Loss

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055259
• Other study ID #: 17-278 MR 1707
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: December 6, 2018

Study information

• Verified date: November 2019
• Source: Edward Via Virginia College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 6, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• mobile Health and Wellness Coaching
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.
• Usual Care
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.

Locations

Country	Name	City	State
United States	Auburn University Pharmaceutical Care Center	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Edward Via Virginia College of Osteopathic Medicine	Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Assessed at baseline and follow-up	6 months (mean 193 ± 21 days)
Secondary	Change Waist Circumference	Assessed at baseline and follow-up	6 months (mean 193 ± 21 days)
Secondary	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)
Secondary	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)
Secondary	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)