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OverweightNCT05929469

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

A study testing App, Fully Automated Kick-Off and Human-Enhanced Kick-Off in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Obesity, Overweight and Obesity
What is being tested?
App, Fully Automated Kick-Off and Human-Enhanced Kick-Off
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUnited States
Study dates
2 Oct 2023to 25 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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.

Read the 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).

Being tested
App, Fully Automated Kick-Off, Human-Enhanced Kick-Off, Check-In, Counseling
Keywords
Behavioral intervention, SMART (sequential multiple assignment randomized trial)
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AppBehavioural

    Participants will receive an mHealth program.

  • Fully Automated Kick-OffBehavioural

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

  • Human-Enhanced Kick-OffBehavioural

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

  • Check-InBehavioural

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

  • CounselingBehavioural

    Participants will receive counseling from a study interventionist.

Study groups in NCT05929469
Study groupRoleWhat they receive
Fully Automated Kick-Off + AppExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Fully Automated Kick-Off
Human-Enhanced Kick-Off + AppExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Human-Enhanced Kick-Off
Fully Automated Kick-Off + App + Check-InExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Fully Automated Kick-Off; Behavioral: Check-In
Fully Automated Kick-Off + App + CounselingExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Fully Automated Kick-Off; Behavioral: Counseling
Human-Enhanced Kick-Off + App + Check-InExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Human-Enhanced Kick-Off; Behavioral: Check-In
Human-Enhanced Kick-Off + App + CounselingExperimentalThis 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.
Receives: Behavioral: App; Behavioral: Human-Enhanced Kick-Off; Behavioral: Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

Secondary outcomes (14)

  1. 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.

    Measured: Baseline, 3 months

  2. 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

    Measured: Baseline, 4 weeks

  3. 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

    Measured: 4 weeks, 3 months

  4. 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.

    Measured: Up to 3 months

  5. 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.

    Measured: Up to 3 months

  6. 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.

    Measured: 3 months

  7. 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.

    Measured: Baseline to 3 months (daily)

  8. Dietary Self-Monitoring Adherence

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

    Measured: Baseline to 3 months (daily)

  9. Physical Activity Self-Monitoring Adherence

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

    Measured: Baseline to 3 months (daily)

  10. Dietary Goal Adherence

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

    Measured: Baseline to 3 months (daily)

  11. Activity Goal Adherence

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

    Measured: Baseline to 3 months (daily)

  12. 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.

    Measured: Baseline, 3 months

  13. 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.

    Measured: Baseline, 3 months

  14. 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.

    Measured: Baseline, 1 week, 4 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start2 Oct 2023
  3. Primary completion25 Apr 2024
  4. Study completion25 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929469
Sponsor's protocol ID
23-0396
Status last verified
Oct 2023
First submitted
13 Jun 2023
Last updated
30 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martinez CE, Nezami BT, Mayer-Davis E, Willis EA, Gorin AA, Tate DF. Results of a pilot sequential multiple assignment randomized trial using counseling to augment a digital weight loss program. Obes Sci Pract. 2024 Nov 7;10(6):e70018. doi: 10.1002/osp4.70018. eCollection 2024 Dec.

    PubMed 39512729

Questions about this trial

What is this clinical trial studying?

A study testing App, Fully Automated Kick-Off and Human-Enhanced Kick-Off in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility- Rate of early nonresponse (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929469, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.

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