Back to resultsPATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Primary Purpose
Overweight, Obesity, Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App
Fully Automated Kick-Off
Human-Enhanced Kick-Off
Check-In
Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Behavioral intervention, SMART (sequential multiple assignment randomized trial)
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Fully Automated Kick-Off + App
Human-Enhanced Kick-Off + App
Fully Automated Kick-Off + App + Check-In
Fully Automated Kick-Off + App + Counseling
Human-Enhanced Kick-Off + App + Check-In
Human-Enhanced Kick-Off + App + Counseling
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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
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.
Acceptability- Attrition
Attrition will be calculated as the number of intervention participants who completed 3-month measures divided by the number who consented to participate.
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.
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.
Dietary Self-Monitoring Adherence
Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.
Physical Activity Self-Monitoring Adherence
Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.
Dietary Goal Adherence
Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.
Activity Goal Adherence
Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.
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 a week day and a weekend day at each timepoint.
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.
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.
Full Information
NCT ID
NCT05929469
First Posted
June 13, 2023
Last Updated
October 2, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Academy of Nutrition and Dietetics
1. Study Identification
Unique Protocol Identification Number
NCT05929469
Brief Title
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Official Title
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Academy of Nutrition and Dietetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Overweight and Obesity
Keywords
Behavioral intervention, SMART (sequential multiple assignment randomized trial)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This initial pilot and feasibility study uses a sequential, multiple assignment, randomized trial (SMART) design to test digital, behavioral weight loss approaches, with or without human support. Sequential randomization will occur at baseline and at the end of 4 weeks. At baseline, participants will be randomized to receive a standard mHealth program and either a a) Fully Automated Kick-Off session, or b) Human-Enhanced Kick-Off session. Using an a priori decision rule after 4 weeks, those for whom the intervention is not effective will be re-randomized and receive one of two doses of human support. The final assessment will be at 3 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fully Automated Kick-Off + App
Arm Type
Experimental
Arm Description
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.
Arm Title
Human-Enhanced Kick-Off + App
Arm Type
Experimental
Arm Description
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.
Arm Title
Fully Automated Kick-Off + App + Check-In
Arm Type
Experimental
Arm Description
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.
Arm Title
Fully Automated Kick-Off + App + Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Human-Enhanced Kick-Off + App + Check-In
Arm Type
Experimental
Arm Description
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.
Arm Title
Human-Enhanced Kick-Off + App + Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
App
Intervention Description
Participants will receive an mHealth program.
Intervention Type
Behavioral
Intervention Name(s)
Fully Automated Kick-Off
Intervention Description
As an orientation to the study, participants will receive a fully automated kick-off session.
Intervention Type
Behavioral
Intervention Name(s)
Human-Enhanced Kick-Off
Intervention Description
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Intervention Type
Behavioral
Intervention Name(s)
Check-In
Intervention Description
Participants will receive a check-in with a study interventionist.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Participants will receive counseling from a study interventionist.
Primary Outcome Measure Information:
Title
Feasibility- Rate of early nonresponse
Description
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
Title
Feasibility- Percentage of participants with missing data at 4 weeks
Description
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
Secondary Outcome Measure Information:
Title
Weight Change- Percent weight change from baseline to 3 months
Description
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
Title
Weight Change- Percent weight change from baseline to 4 weeks
Description
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
Title
Weight Change- Percent weight change from 4 weeks to 3 months
Description
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
Title
Acceptability- Rate of attendance at human support sessions
Description
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
Title
Acceptability- Attrition
Description
Attrition will be calculated as the number of intervention participants who completed 3-month measures divided by the number who consented to participate.
Time Frame
Up to 3 months
Title
Acceptability- Overall program satisfaction rating
Description
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
Title
Weighing Self-Monitoring Adherence
Description
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)
Title
Dietary Self-Monitoring Adherence
Description
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)
Title
Physical Activity Self-Monitoring Adherence
Description
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)
Title
Dietary Goal Adherence
Description
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)
Title
Activity Goal Adherence
Description
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)
Title
Change in Diet
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Physical Activity
Description
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
Title
Change in Motivation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin E Martinez, MS, RD
Phone
919-966-5852
Email
cmartinez@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caitlin Martinez, MS, RD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Martinez, MS, RD
Phone
919-966-5852
Email
cmartinez@unc.edu
First Name & Middle Initial & Last Name & Degree
Caitlin E Martinez, MS, RD
First Name & Middle Initial & Last Name & Degree
Deborah F Tate, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
We'll reach out to this number within 24 hrs