Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04055259
Enrollment
60
Registered
2019-08-13
Start date
2017-08-14
Completion date
2018-12-06
Last updated
2019-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Overweight and Obesity

Keywords

Health and Wellness Coaching

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.

Interventions

BEHAVIORALmobile 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.

BEHAVIORALUsual 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.

Sponsors

Auburn University
CollaboratorOTHER
Edward Via Virginia College of Osteopathic Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Weight6 months (mean 193 ± 21 days)Assessed at baseline and follow-up

Secondary

MeasureTime frameDescription
Change Waist Circumference6 months (mean 193 ± 21 days)Assessed at baseline and follow-up
Change in Self-Reported Physical Activity6 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?
Change in Self-Reported Sleep Quantity6 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.
Change in Self-Reported Daily Caloric Consumption6 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026