A Mobile Health and Wellness Coaching Intervention for Weight Loss

NCT04055259 | Completed

• 1 other identifier: 17-278 MR 1707
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Health Behavior

Keywords

Health and Wellness Coaching

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Assessed at baseline and follow-up

  6 months (mean 193 ± 21 days)

Secondary Outcomes (4)

• Change Waist Circumference

  6 months (mean 193 ± 21 days)

• Change in Self-Reported Physical Activity

  6 months (mean 193 ± 21 days)

• Change in Self-Reported Sleep Quantity

  6 months (mean 193 ± 21 days)

• Change in Self-Reported Daily Caloric Consumption

  6 months (mean 193 ± 21 days)

Study Arms (2)

mobile Health and Wellness Coaching

EXPERIMENTAL

Behavioral: mobile Health and Wellness Coaching

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

mobile Health and Wellness Coaching BEHAVIORAL

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.

mobile Health and Wellness Coaching

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead
• Auburn University: collaborator

Study Sites (1)

Auburn University Pharmaceutical Care Center

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Health Behavior

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joshua C Hollingsworth, PharmD, PhD

  VCOM-Auburn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 13, 2019
• Study Start: August 14, 2017
• Primary Completion: May 7, 2018
• Study Completion: December 6, 2018
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)