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

Obesity Clinical Trial

— Nudge  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836391
• Other study ID #: 16-0775
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: September 16, 2019

Study information

• Verified date: November 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Nudge
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.

Locations

Country	Name	City	State
United States	Department of Health Behavior, University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of person-days with same-day weighing	Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study	from Baseline to Week 12
Primary	Percent of person-days with next-day weighing	Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study	from Baseline to Week 12
Primary	Percent of person-days met active minutes goal on same day	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	from Baseline to Week 12
Primary	Percent of person-days met active minutes goal on next day	Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study	from Baseline to Week 12
Primary	Percent of person-days met red foods goal on same day	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	from Baseline to Week 12
Primary	Percent of person-days met red foods goal on next day	Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study	from Baseline to Week 12
Secondary	Number of active minutes	Total number of active minutes on the day of message randomization (at the participant-day level) across the 12-week study	from Baseline to Week 12
Secondary	Proximal effect of message on total red foods today	Total number of red foods on the day of message randomization (at the participant-day level) across the 12-week study	from Baseline to Week 12
Secondary	Mean weight change	Mean weight change across participants	from Baseline to Week 12