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

Primary Purpose

Overweight and Obesity, Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nudge

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Mobile health, Physical activity, Nutrition, Self-monitoring, Smartphone app, Digital health tools

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nudge Intervention

Arm Description

Each of 7 intervention message options has specific decision rules (including weighed/not weighed and progress toward daily dietary and activity goals) that make a participant eligible to receive a specific intervention type at a specific time (decision points). At each decision point (early morning, morning, midday, and evening), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

Secondary Outcome Measures

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

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

Mean weight change

Mean weight change across participants

Full Information

NCT ID

NCT03836391

First Posted

February 7, 2019

Last Updated

November 11, 2019

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT03836391

Brief Title

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

Acronym

Nudge

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

February 12, 2019 (Actual)

Primary Completion Date

September 16, 2019 (Actual)

Study Completion Date

September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Overweight, Obesity

Keywords

Mobile health, Physical activity, Nutrition, Self-monitoring, Smartphone app, Digital health tools

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Each participant-time point is randomized between intervention message or no intervention message

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nudge Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Nudge

Intervention Description

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 Outcome Measure Information:

Title

Percent of person-days with same-day weighing

Description

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

Time Frame

from Baseline to Week 12

Title

Percent of person-days with next-day weighing

Description

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

Time Frame

from Baseline to Week 12

Title

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

Description

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

Time Frame

from Baseline to Week 12

Title

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

Description

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

Time Frame

from Baseline to Week 12

Title

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

Description

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

Time Frame

from Baseline to Week 12

Title

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

Description

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

Time Frame

from Baseline to Week 12

Secondary Outcome Measure Information:

Title

Number of active minutes

Description

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

Time Frame

from Baseline to Week 12

Title

Proximal effect of message on total red foods today

Description

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

Time Frame

from Baseline to Week 12

Title

Mean weight change

Description

Mean weight change across participants

Time Frame

from Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah F Tate, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carmina G Valle, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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