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.

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

Overweight

Obesity

Overweight and Obesity

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).

Fully Automated Kick-Off

Human-Enhanced Kick-Off

Check-In

Counseling

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

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.

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.

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

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

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.

Attrition will be calculated as the number of intervention participants who completed 3-month measures divided by the number who consented to participate.

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.

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

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

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

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

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

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 a week day and a weekend day at each timepoint.

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.

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.

This arm includes participants who respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, responders to the Fully Automated Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.

This arm includes participants who respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, responders to the Human-Enhanced Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.

This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.

This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.

This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.

This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status