Optimization of Dietary Adherence in a Mobile Weight Loss Intervention

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07582536
Status
Not Yet Recruiting

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Conditions

  • Overweight and/or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Core — BEHAVIORAL
    Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
  • Switch to Simplified Diet Monitoring — BEHAVIORAL
    Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
  • Goal Autonomy/Planning — BEHAVIORAL
    A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
  • Just-in-time (JIT) Messaging — BEHAVIORAL
    Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
  • Coach Sessions — BEHAVIORAL
    Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.

Study Details

The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often. The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach. The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.

Key Dates

Start date
Mar 31, 2027
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
580 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Condition 1
    Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
  • Experimental: Condition 2
    Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
  • Experimental: Condition 3
    Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
  • Experimental: Condition 4
    Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning
  • Experimental: Condition 5
    Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
  • Experimental: Condition 6
    Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging
  • Experimental: Condition 7
    Core + Switch to Simplified Diet Monitoring + Coach Sessions
  • Experimental: Condition 8
    Core + Switch to Simplified Diet Monitoring
  • Experimental: Condition 9
    Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
  • Experimental: Condition 10
    Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
  • Experimental: Condition 11
    Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
  • Experimental: Condition 12
    Core with Standard Diet Monitoring + Goal Autonomy/Planning
  • Experimental: Condition 13
    Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
  • Experimental: Condition 14
    Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging
  • Experimental: Condition 15
    Core with Standard Diet Monitoring + Coach Sessions
  • Experimental: Condition 16
    Core with Standard Diet Monitoring
  • Other: Core Only (Responders)
    Core program (participants who are not randomized in the factorial intervention)

Primary Outcome Measure

Total weeks of dietary goal adherence [ Time Frame: Time of randomization to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Karen E Hatley, MPH
[email protected]
919-966-5852
Brooke T Nezami, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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