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Completed

NCT Number: NCT03836391

Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies

The purpose of this pilot study is to examine the effects of different types of just-in-time intervention messages on daily meeting dietary, activity, and weighing goals in a sample of young adults participating in a mobile-based weight loss program.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Behavior, University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

Public health interventions typically rely on a set schedule of intervention delivery. Advances in technology and computer tailoring allow us to go from a "one size fits all" approach to one that uses digital health data to deliver "just-in-time adaptive interventions," or JITAIs, that can vary the timing, dose, and content of intervention messages to individuals. This pilot study is a micro-randomized trial that evaluates the effects of various intervention message options delivered in JIT moments on meeting dietary, activity, and weighing goals among young adults in a mobile-based weight loss program.

The Nudge study is a 12-week mobile health weight loss program delivered via a native smartphone application. Individuals are asked to track their red foods (high-calorie, high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale. Up to 4 times each day, participants are randomized to receive or not receive intervention messages in order to examine the effects of these intervention message types on meeting daily weighing goals, red food goals, and activity goals. This is a within-subjects design in which each participant serves as their own control, and data is analyzed at the person-day level.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-35
  • BMI of 25-40 kg/m²
  • Not adhering to the US physical activity guidelines of at least 150 moderate-to-vigorous intensity activity minutes/week
  • English-speaking and writing
  • No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, diabetes treated with insulin, history of heart attack or stroke, current treatment for cancer, or inability to walk for exercise
  • Has an iPhone with iOS 11 (or willing to download it) with internet access and text messaging plan
  • Has home wireless access compatible with Fitbit Aria 2 scale (802.11b/g/n)

Exclusion criteria

  • Current participation in another physical activity or weight control program
  • Currently pregnant, pregnant in last 6 months, or planning pregnancy in next 3 months
  • Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, joint or bone problems, or prescription medicine usage for blood pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, diagnosis of alcohol or substance abuse
  • Occupation requires primarily night shift work
  • Owns and uses a physical activity tracker
  • Moving out of area in next 4 months
  • Out of town for a week or more during study period
  • Not willing to attend two study visits

Treatment and study plan

Nudge

Behavioral

Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.

Primary outcomes

  1. Percent of person-days with same-day weighing

    Time frame: from Baseline to Week 12

    Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study

  2. Percent of person-days with next-day weighing

    Time frame: from Baseline to Week 12

    Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study

  3. Percent of person-days met active minutes goal on same day

    Time frame: from Baseline to Week 12

    Percent who met active minutes goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study

  4. Percent of person-days met active minutes goal on next day

    Time frame: from Baseline to Week 12

    Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study

  5. Percent of person-days met red foods goal on same day

    Time frame: from Baseline to Week 12

    Percent who met red foods goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study

  6. Percent of person-days met red foods goal on next day

    Time frame: from Baseline to Week 12

    Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study

Secondary outcomes

  1. Number of active minutes

    Time frame: from Baseline to Week 12

    Total number of active minutes on the day of message randomization (at the participant-day level) across the 12-week study

  2. Proximal effect of message on total red foods today

    Time frame: from Baseline to Week 12

    Total number of red foods on the day of message randomization (at the participant-day level) across the 12-week study

  3. Mean weight change

    Time frame: from Baseline to Week 12

    Mean weight change across participants

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: Nudge

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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