A Mobile Health and Wellness Coaching Intervention for Weight Loss

NCT ID: NCT04055259

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2018-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mobile Health and Wellness Coaching

Group Type EXPERIMENTAL

mobile Health and Wellness Coaching

Intervention Type 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.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Auburn University

OTHER

Sponsor Role collaborator

Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua C Hollingsworth, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

VCOM-Auburn

Locations

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Auburn University Pharmaceutical Care Center

Auburn, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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17-278 MR 1707

Identifier Type: -

Identifier Source: org_study_id

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