ClinicalTrials.gg
CompletedNCT06856551Updated Apr 17, 2025

Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention

An interventional study of Minimal contact control and Promotion and Prevention Interventions in Weight Control, sponsored by University of North Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by University of North Florida · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 years 3 months after the study started (first participant enrolled Oct 2015, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Weight Control
03

In context

Lead sponsor

University of North Florida is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18+ years old
  • generally healthy
  • between 18.5 and 35

Exclusion criteria

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
  • \< 18.5, >35.0
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Minimal contact control

    Participants in the control group received a pamphlet about general dietary and physical activity guidelines.

    Behavioral: Minimal contact control

  • 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.

    Behavioral: Promotion and Prevention Interventions

  • 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.

    Behavioral: Promotion and Prevention Interventions

Interventions

  • BehavioralMinimal contact control

    Participants in the control group received a pamphlet about general dietary and physical activity guidelines.

  • BehavioralPromotion and Prevention Interventions

    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

06

What researchers measure

Primary outcomes

  1. Weight Change

    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).

    Time frame: baseline, 3 months, 6 months

Secondary outcomes

  1. meal regularity change

    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).

    Time frame: baseline, 3 months

  2. fast-food eating change

    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).

    Time frame: baseline, 3 months

  3. screen related eating and viewing change

    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).

    Time frame: baseline, 3 months

  4. dietary modifications change

    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).

    Time frame: baseline, 3 months

  5. self-monitoring change

    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).

    Time frame: baseline, 3 months

  6. self-weighing change

    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).

    Time frame: baseline, 3 months

  7. physical activity change

    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).

    Time frame: baseline, 3 months

07

Study locations

1 site
  • University of North Florida
    Jacksonville, Florida 32224, United States
08

References and documents

Individual participant data

Plan to share: Yes — Will be shared on open science framework.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2015 to primary completion in Mar 2017, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2025
First posted
Mar 4, 2025
StartActual
Oct 30, 2015
Primary completionActual
Mar 20, 2017
CompletionActual
Mar 20, 2017
Last update
Apr 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06856551
Lead sponsor
University of North Florida
Responsible party
Paul Fuglestad (Associate Professor, University of North Florida) — Principal investigator
First posted
Mar 4, 2025
Start date
Oct 30, 2015
Primary completion
Mar 20, 2017
Completion
Mar 20, 2017
Last update
Apr 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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