A Mobile Health and Wellness Coaching Intervention for Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Health Behavior
• Intervention / Treatment: Behavioral: mobile Health and Wellness Coaching; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University Pharmaceutical Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: 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.
Experimental: mobile Health and Wellness Coaching	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Edward Via Virginia College of Osteopathic Medicine
• Collaborators: Auburn University
• Investigators: Principal Investigator: Joshua C Hollingsworth, PharmD, PhD, VCOM-Auburn

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): May 7, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Health and Wellness Coaching
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 17-278 MR 1707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are currently no plans to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No