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A Mobile Health and Wellness Coaching Intervention for Weight Loss

Not Applicable
Completed
Conditions
Overweight and Obesity
Health Behavior
Interventions
Behavioral: mobile Health and Wellness Coaching
Behavioral: Usual Care
Registration Number
NCT04055259
Lead Sponsor
Edward Via Virginia College of Osteopathic Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
mobile Health and Wellness Coachingmobile Health and Wellness Coaching-
Usual CareUsual Care-
Primary Outcome Measures
NameTimeMethod
Change in Weight6 months (mean 193 ± 21 days)

Assessed at baseline and follow-up

Secondary Outcome Measures
NameTimeMethod
Change Waist Circumference6 months (mean 193 ± 21 days)

Assessed at baseline and follow-up

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 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 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.

Trial Locations

Locations (1)

Auburn University Pharmaceutical Care Center

🇺🇸

Auburn, Alabama, United States

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