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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05929469
• Other study ID #: 23-0396
• Status: Completed
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: April 25, 2024

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 25, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• App
Participants will receive an mHealth program.
• Fully Automated Kick-Off
As an orientation to the study, participants will receive a fully automated kick-off session.
• Human-Enhanced Kick-Off
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
• Check-In
Participants will receive a check-in with a study interventionist.
• Counseling
Participants will receive counseling from a study interventionist.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks
Secondary	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.	Baseline, 3 months
Secondary	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	Baseline, 4 weeks
Secondary	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	4 weeks, 3 months
Secondary	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.	Up to 3 months
Secondary	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.	Up to 3 months
Secondary	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.	3 months
Secondary	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.	Baseline to 3 months (daily)
Secondary	Dietary Self-Monitoring Adherence	Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.	Baseline to 3 months (daily)
Secondary	Physical Activity Self-Monitoring Adherence	Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.	Baseline to 3 months (daily)
Secondary	Dietary Goal Adherence	Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.	Baseline to 3 months (daily)
Secondary	Activity Goal Adherence	Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.	Baseline to 3 months (daily)
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 1 week, 4 weeks, 3 months