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Completed

NCT Number: NCT04055259

A Mobile Health and Wellness Coaching Intervention for Weight Loss

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University Pharmaceutical Care Center

Auburn, Alabama, 36849, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Weight

    Time frame: 6 months (mean 193 ± 21 days)

    Assessed at baseline and follow-up

Secondary outcomes

  1. Change Waist Circumference

    Time frame: 6 months (mean 193 ± 21 days)

    Assessed at baseline and follow-up

  2. Change in Self-Reported Physical Activity

    Time frame: 6 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?

  3. Change in Self-Reported Sleep Quantity

    Time frame: 6 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.

  4. Change in Self-Reported Daily Caloric Consumption

    Time frame: 6 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.

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Collaborators

  • Auburn University

Registry information

Official study title

Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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