- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110273
Fit for Duty: mHealth Intervention for Weight Gain Prevention
Preventing Weight Gain in U.S. Air Force Personnel Using a Novel Mobile Health Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen E. Hatley, MPH, RD
- Phone Number: 919-966-5853
- Email: keericks@email.unc.edu
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 28236
- Recruiting
- Joint Base San Antonio-Lackland
-
Contact:
- Annette Martinez
-
Principal Investigator:
- Gerald W Talcott, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 18-39
- body mass index (BMI) of 21-30 kg/m^2
- own a smartphone with a data and text messaging plan;
- Active-Duty Air Force stationed at Joint Base San Antonio - Lackland, Joint Base San Antonio - Ft. Sam Houston, Sheppard Air Force Base or Keesler Air Force Base
- Anticipate being at their Station 12 months or more
- Willing and able to wear a Fitbit activity tracker daily for the duration of the study
Exclusion Criteria:
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months.
- Previous surgical procedure for weight loss in past 5 years or planned weight loss surgery in the next year.
- Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa).
- Another member of the household is a participant in this same study
- Currently participating in a commercial weight loss program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: m-Health Control
This arm receives a digital fitness tracker, digital scale, and basic information about behavioral approaches for weight gain prevention.
|
Participants receive digital tools and education on weight gain prevention behaviors at baseline.
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Experimental: Fit for Duty Mobile
This arm receives a digital fitness tracker; digital scale; smartphone app which delivers a behavioral weight gain prevention intervention; and periodic coaching calls.
|
Fit for Duty-mobile participants will receive self-regulatory support and behavior change techniques via an initial core intervention delivered through a native smartphone app (includes connected device data, 10 weekly lessons, weekly tailored feedback) and 4 coaching calls (weeks 1, 4, 8, and 16).
App based tailored feedback and messaging will continue through 2 years.
Optional 4-week refresher e-campaigns are offered every 6 mos.
after the initial core intervention.
Participants choose to follow either a Small Changes approach or a Large Changes approach and may choose to switch approaches over the 2 years, if desired.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: Baseline, 2 years
|
Absolute weight change from baseline to 2 years.
Weight will be objectively measured on a digital scale in the participant's home.
|
Baseline, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: Baseline, up to 12 months
|
Absolute weight change from baseline up to 12 months.
Weight will be objectively measured on a digital scale in the participant's home.
|
Baseline, up to 12 months
|
Prevention of weight gain
Time Frame: 2 years
|
Proportion of participants in each study group (mHealth Control and Fit for Duty Mobile) that prevents weight gain at 2 years.
|
2 years
|
Change in Competence for Diet and Physical Activity
Time Frame: Baseline, 4 months, 12 months, 24 months
|
Change in perceived competence from baseline up to 24 months as measured using 2 items from the The Perceived Competence for Scale.
The Scale measures perceived competence for diet (4 items) and physical activity (4 items) and there are two subscales (diet and physical activity).
Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true).
One item from each subscale will be measured: "I feel confident in my ability to maintain a healthy diet" and "I feel confident in my ability to exercise regularly."
The range for each item in each subscale is 1 - 7 with greater values indicating higher levels of perceived competence for engaging in positive diet and physical activity behaviors.
|
Baseline, 4 months, 12 months, 24 months
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Change in Weight Control Strategies
Time Frame: Baseline, up to 24 months
|
Participants will be asked about frequency of use of 30 weight control strategies such as "I set a daily calorie goal for myself" used in the past month on a 5-point Likert scale from Never to Always.
A total score is computed and ranges from 0 to 120 with higher scores indicating more frequent usage of the strategies.
Factor analysis reflects a 4-factor structure: dietary choices, self-monitoring strategies, physical activity, and psychological coping.
|
Baseline, up to 24 months
|
Eating Disorder Symptoms - Loss of Control Eating
Time Frame: Baseline, up to 24 months
|
Participants will respond to an item derived from the revised Questionnaire on Eating and Weight Patterns (QEWP-5) to assess loss of control eating.
Loss of control eating is assessed by endorsing the behavior one or more times per week over the reference period.
|
Baseline, up to 24 months
|
Eating Disorder Symptoms - Compensatory Behavior
Time Frame: Baseline, up to 24 months
|
Participants will respond to an items derived from the revised Questionnaire on Eating and Weight Patterns (QEWP-5) to assess compensatory behaviors.
Compensatory behaviors are assessed as using any, on average, once per week during the reference period.
|
Baseline, up to 24 months
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Change in self-efficacy for physical activity
Time Frame: Baseline, up to 24 months
|
The scale, consists of five items assessing confidence in participating in exercise in the presence of barriers such as feeling tired, being in a bad mood, not having time, on vacation, and experiencing bad weather.
Response options are on a five point Likert-scale, ranging from not confident (1) to extremely confident (5).
The score is an average of each item with a higher score indicating higher self-efficacy.
Scores range from 1 to 5 with 5 indicating higher self-efficacy.
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Baseline, up to 24 months
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Change in Self-Regulation for Managing Weight
Time Frame: Baseline, up to 24 months
|
We will adapt the 15-item Dietary Self-Regulation Questionnaire to assess reasons for starting or continuing to manage weight (The reason I would manage my weight is...".
Items are rated on a 7 point Likert scale from 1 (not at all true) to 7 (very true).
Subscales include autonomous motivation (1, 3, 6, 8, 11, 13), externally controlled motivation (2, 4, 7, 9, 12, 14), and amotivation (5, 10, 15).
Responses for each subscale score are averaged and higher numbers indicate higher levels of that type of motivation.
Subscale scores range from 1 to 7.
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Baseline, up to 24 months
|
Reach (Re-AIM)
Time Frame: Baseline
|
The number of potential participants approached, eligible and enrolled will be measured.
Participation rate will be determined by dividing the total number of enrolled participants by the total number eligible to enroll.
|
Baseline
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Representativeness (Re-AIM)
Time Frame: Baseline
|
Representativeness will be assessed by comparing demographics, BMI and rank of those enrolled to: 1) those screened, eligible, and not enrolled and 2) to the demographics of the personnel at the study installations, the Air Force, and the US Military.
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Baseline
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Change in Dietary Intake as measured by the ASA-24 hour Recall
Time Frame: Baseline, up to 24 months
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Changes in dietary intake from baseline up to 24 months will be assessed using the NCI Automated Self-Administered 24-hour Recall (ASA-24).
Participants will complete one self-reported recall.
Change in overall energy intake and saturated fat intake, as well as change in fruit and vegetable consumption, fiber consumption, and change in the Healthy Eating Inventory scores will be examined.
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Baseline, up to 24 months
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Change in Physical Activity as measured by the Fitbit Activity Tracker
Time Frame: Baseline, up to 24 months
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Change in physical activity from baseline up to 24 months as measured using 1 week of data collected using the Fitbit activity monitor during each assessment period including total minutes of activity and steps.
|
Baseline, up to 24 months
|
Change in Perceived Quality of Life as measured by the CDC Health Days Measure
Time Frame: Baseline, up to 24 months
|
The Centers for Disease Control and Prevention (CDC) Healthy Days Measure assesses a person's perceived sense of well-being through four questions on: 1) self-rated health, 2) number of recent days when physical health was not good, 3) number of recent days when mental health was not good, and 4) number of recent activity limitation days because of poor physical or mental health. Recent days is past 30. Scoring for this measurement tool is limited to an unhealthy days summary index is calculated by adding numbers 2 and 3 above with a maximum of 30 with higher values indicating poorer health. For self-rated health, items include Excellent, Very Good, Good, Fair, and Poor. For items 2-4, a greater number of days indicates more poor health in each category. |
Baseline, up to 24 months
|
Change in Depression as measured by the CESD-Short Form
Time Frame: Baseline, up to 24 months
|
Center for Epidemiological Studies Depression Scale-Short Form (CESD) is a self-report 10-item scale designed to measure current depressive symptoms.
Total score range from 0-30, with a score at or above 10 reflecting significant depressive symptomatology.
|
Baseline, up to 24 months
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Change in Perceived Stress as measured by the Perceived Stress Scale
Time Frame: Baseline, up to 24 months
|
The 4-item Perceived Stress Scale measures overall perceived stress during the past month.
Items include how often you felt you could control the important things in your life, you felt confident about your ability to handle your personal problems, things were going your way, and you felt difficulties were piling up so you could not overcome them.
Items are scored on as 5-point Likert scale from 0 (never) to 4 (very often).
Scores range from 0 to 16, and higher scores indicate more stress.
|
Baseline, up to 24 months
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Change in goal setting self-regulation behaviors as measured by the Short Self-Regulation Questionnaire Goal Setting subscale
Time Frame: Baseline, up to 24 months
|
Self-regulation behaviors will be assessed using the 10-item Goal Setting subscale of the Short Self-Regulation Questionnaire.
Items are scored on a 1-5 scale (1=strongly disagree to 5=strongly agree ) and are be summed to create a total score with a maximum of 50 with higher scores indicating greater goal setting behaviors.
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Baseline, up to 24 months
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Change in Self-Efficacy for Diet as measured by the WEL-Q
Time Frame: Baseline, up to 24 months
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The Weight Efficacy Lifestyle Questionnaire (WEL-Q)) Short Form will be used to assess participants' confidence in their ability to handle high-risk situations related to eating; 8 items ask participants to rate their confidence on an 11-point Likert scale ranging from 0 (not confident) to 10 (very confident).
The WEL consists of five factors: negative emotions, availability, social pressure, physical discomfort, and positive activities.
Items are summed for a total score (0-80).
Higher scores indicated higher levels of self-efficacy for resisting eating.
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Baseline, up to 24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation (Re-AIM)
Time Frame: Baseline to 24 months (across intervention)
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Fidelity of recruitment strategies: Estimates of potentially eligible participants will be measured by attendance records from recruitment events.
Source of recruitment will be self-reported by participants. .
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Baseline to 24 months (across intervention)
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Implementation (Re-AIM) coaching calls
Time Frame: Baseline to 24 months (across intervention)
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Fidelity of coaching calls: Will be measured by call completion records and staff checklist of intervention strategies delivered.
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Baseline to 24 months (across intervention)
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Implementation (Re-AIM) app usage
Time Frame: Baseline to 24 months (across intervention)
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Fidelity of app usage: Will be measured by examining objective measures of logins, feature utilization, and content exposure.
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Baseline to 24 months (across intervention)
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Effectiveness (Re-AIM)
Time Frame: 24 months
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Effectiveness will be measured primarily with the study's weight gain outcomes over time.
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24 months
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Effectiveness (Re-AIM)
Time Frame: up to 24 months
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Effectiveness will also be measured by examining potential negative outcomes (e.g., loss of control eating and compensatory behavior, attrition) will also be used.
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up to 24 months
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Adoption (Re-AIM)
Time Frame: 24 months
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Potential for Organizational level Adoption will be estimated by summarizing stakeholders' willingness and perceptions of future adoption of SNAP-M for other bases and military branches.
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Deborah F. Tate, PhD, professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1405
- 1R01HL161836-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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