NCT06856551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

April 17, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 14, 2025

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

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).

    baseline, 3 months, 6 months

Secondary Outcomes (7)

  • meal regularity change

    baseline, 3 months

  • fast-food eating change

    baseline, 3 months

  • screen related eating and viewing change

    baseline, 3 months

  • dietary modifications change

    baseline, 3 months

  • self-monitoring change

    baseline, 3 months

  • +2 more secondary outcomes

Study Arms (3)

Minimal contact control

ACTIVE COMPARATOR

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

Behavioral: Minimal contact control

Promotion focus group

EXPERIMENTAL

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

Prevention focus group

EXPERIMENTAL

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

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

Minimal contact 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

Prevention focus groupPromotion focus group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 4, 2025

Study Start

October 30, 2015

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

April 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Will be shared on open science framework.

Locations