A Mobile Health and Wellness Coaching Intervention for Weight Loss

Sponsor
Edward Via Virginia College of Osteopathic Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04055259
Collaborator
Auburn University (Other)
60
1
2
15.7
3.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mobile Health and Wellness Coaching
  • Behavioral: Usual Care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss
Actual Study Start Date :
Aug 14, 2017
Actual Primary Completion Date :
May 7, 2018
Actual Study Completion Date :
Dec 6, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Weight [6 months (mean 193 ± 21 days)]

    Assessed at baseline and follow-up

Secondary Outcome Measures

  1. Change Waist Circumference [6 months (mean 193 ± 21 days)]

    Assessed at baseline and follow-up

  2. Change in Self-Reported Physical Activity [6 months (mean 193 ± 21 days)]

    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?

  3. Change in Self-Reported Sleep Quantity [6 months (mean 193 ± 21 days)]

    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.

  4. Change in Self-Reported Daily Caloric Consumption [6 months (mean 193 ± 21 days)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Auburn University Pharmaceutical Care Center Auburn Alabama United States 36849

Sponsors and Collaborators

  • Edward Via Virginia College of Osteopathic Medicine
  • Auburn University

Investigators

  • Principal Investigator: Joshua C Hollingsworth, PharmD, PhD, VCOM-Auburn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward Via Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT04055259
Other Study ID Numbers:
  • 17-278 MR 1707
First Posted:
Aug 13, 2019
Last Update Posted:
Nov 7, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Edward Via Virginia College of Osteopathic Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2019