- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06856551
Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention
April 14, 2025 updated by: Paul Fuglestad, University of North Florida
The study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors.
The lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity.
It was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months.
Conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months.
It was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing.
Furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- University of North Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18+ years old
- generally healthy
- BMI between 18.5 and 35
Exclusion Criteria:
- pregnancy within the past 6 months
- current pregnancy
- plan to get pregnant in the next 6 months
- serious physical or psychological problems that would contraindicate participation in a weight-related program
- history of anorexia or bulimia
- diabetes or hypertension
- current participation in a weight-loss program
- BMI < 18.5, >35.0
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Minimal contact control
Participants in the control group received a pamphlet about general dietary and physical activity guidelines.
|
Participants in the control group received a pamphlet about general dietary and physical activity guidelines.
|
|
Experimental: Promotion focus group
Participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses.
Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal).
All messages and study tasks were framed in terms of promotion focus.
Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control.
|
regulatory focus groups, participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses.
Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal).
The informational content and intervention procedures were identical except for the framing of messages and tasks.
The prevention messages emphasized protecting one's health (e.g., failing to regularly exercise can undermine your weight control program and lead to poor health; if you do not vigilantly follow these behaviors, you will not fulfill your weight control goals or protect your health and well-being; not eating fruits and vegetables results in failure to supply the body with the nutrients it needs).
The promotion messages emphasized promoting one's health
|
|
Experimental: Prevention focus group
Participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses.
Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal).
All messages and study tasks were framed in terms of prevention focus.
Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control.
|
regulatory focus groups, participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses.
Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal).
The informational content and intervention procedures were identical except for the framing of messages and tasks.
The prevention messages emphasized protecting one's health (e.g., failing to regularly exercise can undermine your weight control program and lead to poor health; if you do not vigilantly follow these behaviors, you will not fulfill your weight control goals or protect your health and well-being; not eating fruits and vegetables results in failure to supply the body with the nutrients it needs).
The promotion messages emphasized promoting one's health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change
Time Frame: baseline, 3 months, 6 months
|
Participant were weighed by study staff during a baseline measurement session (M = 153.7 lb, SD = 31.6)
and then again after 6 months (M = 149.9
lb, SD = 28.9).
Weight was self-reported at 3 months (M = 150.7 lb, SD = 29.4).
|
baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
meal regularity change
Time Frame: baseline, 3 months
|
Participants were asked about the number of times in a typical week they 1) ate breakfast, 2) ate lunch, and 3) ate dinner.
They responded on a 5-point scale: 0 times, 1-2 times, 3-4 times, 5-6 times, or 7+ times.
Mean scores were created for the baseline measurement session (M = 4.00, SD = .73)
and for the 3-month measurement session (M = 4.17, SD = .72).
|
baseline, 3 months
|
|
fast-food eating change
Time Frame: baseline, 3 months
|
Participants were asked about the number of times in a typical week they 1) ate food prepared at a fast-food restaurant and 2) purchased food at a convenience store/ gas station.
They responded on a 5-point scale: 0 times, 1-2 times, 3-4 times, 5-6 times, or 7+ times.
Mean scores were created for the baseline measurement session (M = 1.74,
SD = .66)
and for the 3-month measurement session (M = 1.63,
SD = .53).
|
baseline, 3 months
|
|
screen related eating and viewing change
Time Frame: baseline, 3 months
|
Participants indicated the frequency per week that they 1) ate a meal while watching TV, 2) ate a snack while watching TV, and 3) ate after 8 pm.
The participants responded by using a 5-point scale: 0 times, 1-2 time, 3-4 times, 5-6 times, or 7+ times.
They also indicated the number of hours on an average day that they 4) use a phone/tablet/computer, 5) watch TV and 6) sit or recline (not including sleeping).
Their responses were recorded on a 7-point scale: 0, <1 hour, 1 hour, 2 hours, 3 hours, 4 hours, or 5+ hours.
Mean scores across the six items were calculated for the baseline measurement session (M = 3.44, SD = .90)
and the 3-month measurement session (M = 3.34, SD = .90).
|
baseline, 3 months
|
|
dietary modifications change
Time Frame: baseline, 3 months
|
Dietary modification was measured by asking participants how often they 1) reduced/limited their portions, 2) decreased/limited snacks, 3) decreased/limited sweets, 4) decreased/limited fried food, 5) decreased/limited carbs, 6) decreased/limited fat, 7) ate fruits and vegetables, and 8) planned meals.
Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often.
Mean scores were calculated for the baseline measurement session (M = 2.96, SD = 0.74) and for the 3-month measurement session (M = 3.32, SD = 0.73).
|
baseline, 3 months
|
|
self-monitoring change
Time Frame: baseline, 3 months
|
For self-monitoring, participants were asked how often they wrote down the calorie content of the foods they ate and the amount and types of exercise they did.
Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often.
Mean scores were then calculated for the baseline measurement session (M = 1.86,
SD = 1.03) and for the 3-month measurement session (M = 2.85, SD = 1.26).
|
baseline, 3 months
|
|
self-weighing change
Time Frame: baseline, 3 months
|
At baseline, participants responded to the question "How often do you weigh yourself?" on a 7-point scale: never, about once a year or less, every couple of months, every month, every week, every day, or more than once a day (M = 3.83, SD = 1.31).
At 3 months, they responded to the question "In the past week, how many times did you weigh yourself?" on a 5-point scale: never, 1-2 times, 3-4 times, 5-6 times, or 7 or more times (M = 2.01, SD = 1.02).
|
baseline, 3 months
|
|
physical activity change
Time Frame: baseline, 3 months
|
To measure physical activity, participants were asked how often they 1) planned their exercise, 2) walked for at least 30 minutes at a time, and 3) engaged in other moderate to vigorous exercise.
Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often.
Mean scores were calculated for the baseline measurement session (M = 3.31, SD = .94)
and for the 3-month measurement session (M = 3.55, SD = 1.08).
|
baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2015
Primary Completion (Actual)
March 20, 2017
Study Completion (Actual)
March 20, 2017
Study Registration Dates
First Submitted
February 14, 2025
First Submitted That Met QC Criteria
February 25, 2025
First Posted (Actual)
March 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 17, 2025
Last Update Submitted That Met QC Criteria
April 14, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 724308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Will be shared on open science framework.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.