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A Mobile Health and Wellness Coaching Intervention for Weight Loss

Primary Purpose

Overweight and Obesity, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mobile Health and Wellness Coaching
Usual Care
Sponsored by
Edward Via Virginia College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Health and Wellness Coaching

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Auburn University Pharmaceutical Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mobile Health and Wellness Coaching

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Change in Weight
Assessed at baseline and follow-up

Secondary Outcome Measures

Change Waist Circumference
Assessed at baseline and follow-up
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?
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.
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.

Full Information

First Posted
August 7, 2019
Last Updated
November 6, 2019
Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
Auburn University
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1. Study Identification

Unique Protocol Identification Number
NCT04055259
Brief Title
A Mobile Health and Wellness Coaching Intervention for Weight Loss
Official Title
Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
Auburn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Health Behavior
Keywords
Health and Wellness Coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mobile Health and Wellness Coaching
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
mobile Health and Wellness Coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight
Description
Assessed at baseline and follow-up
Time Frame
6 months (mean 193 ± 21 days)
Secondary Outcome Measure Information:
Title
Change Waist Circumference
Description
Assessed at baseline and follow-up
Time Frame
6 months (mean 193 ± 21 days)
Title
Change in Self-Reported Physical Activity
Description
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?
Time Frame
6 months (mean 193 ± 21 days)
Title
Change in Self-Reported Sleep Quantity
Description
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.
Time Frame
6 months (mean 193 ± 21 days)
Title
Change in Self-Reported Daily Caloric Consumption
Description
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.
Time Frame
6 months (mean 193 ± 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua C Hollingsworth, PharmD, PhD
Organizational Affiliation
VCOM-Auburn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University Pharmaceutical Care Center
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are currently no plans to share IPD with other researchers.

Learn more about this trial

A Mobile Health and Wellness Coaching Intervention for Weight Loss

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