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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Participants will receive an mHealth program.
As an orientation to the study, participants will receive a fully automated kick-off session.
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Participants will receive a check-in with a study interventionist.
Participants will receive counseling from a study interventionist.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Feasibility- Rate of early nonresponse
The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.
Time frame: 4 weeks
Feasibility- Percentage of participants with missing data at 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.
Time frame: 4 weeks
Weight Change- Percent weight change from baseline to 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.
Time frame: Baseline, 3 months
Weight Change- Percent weight change from baseline to 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
Time frame: Baseline, 4 weeks
Weight Change- Percent weight change from 4 weeks to 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
Time frame: 4 weeks, 3 months
Acceptability- Rate of attendance at human support sessions
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.
Time frame: Up to 3 months
Acceptability- Attrition
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.
Time frame: Up to 3 months
Acceptability- Overall program satisfaction rating
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.
Time frame: 3 months
Weighing Self-Monitoring Adherence
Number of days of self-weighing over the 3 month period, measured by use of the scale in the participant's home.
Time frame: Baseline to 3 months (daily)
Dietary Self-Monitoring Adherence
Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.
Time frame: Baseline to 3 months (daily)
Physical Activity Self-Monitoring Adherence
Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.
Time frame: Baseline to 3 months (daily)
Dietary Goal Adherence
Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.
Time frame: Baseline to 3 months (daily)
Activity Goal Adherence
Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.
Time frame: Baseline to 3 months (daily)
Change in Diet
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.
Time frame: Baseline, 3 months
Change in Physical Activity
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.
Time frame: Baseline, 3 months
Change in Motivation
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.
Time frame: Baseline, 1 week, 4 weeks, 3 months
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