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Completed

NCT Number: NCT05929469

PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches

The purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (SMART) design. All participants in this pilot trial will receive a 3-month mobile health (mHealth) program. The dose of human support will vary by first- and second-line randomizations. The feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

Ninety-nine adults, ages 18-65, with overweight or obesity, will be randomized in total. All participants will receive an mHealth program (App) for program duration that includes activity tracking with a Fitbit, weight tracking with a smart scale, and an app for diet tracking. At baseline, participants will be randomized to either a a) Fully Automated Kick-Off, or b) Human-Enhanced Kick-Off. "Early responders" will continue with to use App, alone. After 4 weeks, "early non-responders" in both arms will be re-randomized once to one of two augmented interventions with human support: Counseling or Check-In. Assessments will occur at baseline, 1 week, 4 weeks, and 3 months to explore feasibility, acceptability, and preliminary outcomes (weight, self-monitoring adherence, behavioral goal adherence).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current age: 18-65 years
  • Lives in North Carolina
  • Body mass index (BMI) of 27.5-45 kg/m^2
  • Ability to read, write, and speak English
  • Ownership of iPhone with a data and texting plan
  • Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
  • Is not living a participant or staff member on this trial
  • Willingness to be randomized to any of the treatment sequences

Exclusion criteria

  • Weight loss of more than 10 pounds in the last 6 months that was maintained
  • A history of weight loss surgery
  • Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
  • Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
  • Have recently been diagnosed or treated for cancer
  • Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
  • Report taking prescription or over the counter medication with a known impact on metabolism or weight
  • Report a history of an eating disorder
  • History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
  • History of alcohol or substance abuse
  • Current participation in another weight loss program that may interfere with participation in this study

Treatment and study plan

App

Behavioral

Participants will receive an mHealth program.

Fully Automated Kick-Off

Behavioral

As an orientation to the study, participants will receive a fully automated kick-off session.

Human-Enhanced Kick-Off

Behavioral

As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.

Check-In

Behavioral

Participants will receive a check-in with a study interventionist.

Counseling

Behavioral

Participants will receive counseling from a study interventionist.

Primary outcomes

  1. Feasibility- Rate of early nonresponse

    Time frame: 4 weeks

    The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.

  2. Feasibility- Percentage of participants with missing data at 4 weeks

    Time frame: 4 weeks

    The percentage of participants with missing data at 4 weeks will be calculated as the number of participants who do not complete the 4-week weight assessment divided by the total number of participants randomized.

Secondary outcomes

  1. Weight Change- Percent weight change from baseline to 3 months

    Time frame: Baseline, 3 months

    Percent weight change from baseline to 3 months will be calculated ((3 month weight - baseline weight)/100). Weight will be objectively measured on a scale in the participant's home.

  2. Weight Change- Percent weight change from baseline to 4 weeks

    Time frame: Baseline, 4 weeks

    Percent weight change from baseline to 4 weeks will be calculated ((4 week weight - baseline weight)/100). Weight will be objectively measured on a scale in the participant's home

  3. Weight Change- Percent weight change from 4 weeks to 3 months

    Time frame: 4 weeks, 3 months

    Percent weight change from 4 weeks to 3 months will be calculated ((3 month weight - 4 week weight)/100). Weight will be objectively measured on a scale in the participant's home

  4. Acceptability- Rate of attendance at human support sessions

    Time frame: Up to 3 months

    The rate of attendance at human support sessions will be calculated as the number of human sessions completed divided by the number of human sessions assigned.

  5. Acceptability- Attrition

    Time frame: Up to 3 months

    Attrition will be calculated as the number of intervention participants who did not complete 3-month weight measures divided by the number randomized to treatment.

  6. Acceptability- Overall program satisfaction rating

    Time frame: 3 months

    Overall program satisfaction will be assessed using a single item, which asks participants to rate their overall satisfaction with the program on a 4-point Likert scale that ranges from "very dissatisfied" to "very satisfied," in which higher scores indicate greater levels of satisfaction.

  7. Weighing Self-Monitoring Adherence

    Time frame: Baseline to 3 months (daily)

    Number of days of self-weighing over the 3 month period, measured by use of the scale in the participant's home.

  8. Dietary Self-Monitoring Adherence

    Time frame: Baseline to 3 months (daily)

    Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.

  9. Physical Activity Self-Monitoring Adherence

    Time frame: Baseline to 3 months (daily)

    Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.

  10. Dietary Goal Adherence

    Time frame: Baseline to 3 months (daily)

    Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.

  11. Activity Goal Adherence

    Time frame: Baseline to 3 months (daily)

    Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.

  12. Change in Diet

    Time frame: Baseline, 3 months

    Change in daily caloric intake from baseline to 3 months, as measured using the self- administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on one day at each timepoint.

  13. Change in Physical Activity

    Time frame: Baseline, 3 months

    Change in physical activity from baseline to 3 months, as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum.

  14. Change in Motivation

    Time frame: Baseline, 1 week, 4 weeks, 3 months

    Change in motivation from baseline to 4 weeks and 3 months, as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for weight management. Six items assess autonomous motivation and six assess controlled motivation using a 7 point Likert scale, in which 1 corresponds to "not at all true" and 7 corresponds to "very true." Items will be averaged to produce scores for autonomous motivation and controlled motivation ranging from 1-7. Higher values on each sub-scale indicate greater levels of that type of motivation. A Relative Autonomous Index (RAI) score will be separately calculated by subtracting the controlled motivation score from the autonomous motivation score. The range of possible RAI scores is -6 to 6.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Academy of Nutrition and Dietetics

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
May 30, 2024

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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