NCT03932994

Brief Summary

This project will develop and test an online health promotion program that augments diet and physical activity behavior change methods using acceptance and commitment therapy (ACT). ACT is an evidence-based cognitive behavioral therapy found to be effective in over 200 randomized controlled trials (RCTs) in improving a wide range of psychological and behavioral health problems. Recently, several clinical trials have found ACT enhances diet and exercise behavior as well as long term weight management. These studies have focused on testing ACT provided by experts in face-to-face interventions, which limits broad dissemination. Delivering an ACT health promotion program online could potentially provide a low-cost resource to improve health across Utah. The specific aims are to:

  1. 1.Develop a canvas-based online course (ACT on Health) that teaches how to improve diet and physical activity as well as ACT-based skills to enhance behavior change efforts.
  2. 2.Evaluate ACT on Health relative to a waitlist in a RCT with 60 overweight/obese adults on outcomes including self-reported physical activity, diet, and quality of life.
  3. 3.Participants will report a high degree of satisfaction and will demonstrate adequate engagement in the ACT on Health program.
  4. 4.Participants assigned to ACT on Health will improve more on self-reported diet, physical activity, and quality of life relative to the waitlist condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 15, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

April 15, 2019

Last Update Submit

March 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

    Asks participants to report on the specific foods they ate over the past day to measure specific nutritional intake

    24 hours

Secondary Outcomes (6)

  • International Physical Activity Questionnaire (IPAQ)

    1 week

  • Three Factor Eating Questionnaire (TFEQ)

    8 weeks

  • Weight Control Strategies Scale (WCSS)

    8 weeks

  • General Health Questionnaire (GHQ) General Health Questionnaire

    2 weeks

  • Weight Self Stigma Questionnaire (WSSQ)

    During the past month

  • +1 more secondary outcomes

Study Arms (2)

ACT on Health Intervention

EXPERIMENTAL

Those assigned to ACT on Health will use the program over the next 8 weeks, completing weekly modules and coaching calls.

Behavioral: ACT on Health

Waitlist

NO INTERVENTION

Those assigned to the waitlist will simply wait 8 weeks. A second online assessment will be completed 8 weeks after baseline in both conditions (for a between condition comparison). After the second assessment, waitlist participants will gain access to ACT on Health.

Interventions

ACT on HealthBEHAVIORAL

This intervention consists of an online canvas course based on Acceptance and Commitment Therapy, focused on increasing healthy diet and physical activity and addressing barriers to change. The intervention also consists of weekly phone coaching calls.

ACT on Health Intervention

Eligibility Criteria

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

You may qualify if:

  • Being 18 or older.
  • Being a fluent English speaker.
  • A self-reported body mass index of 25 or higher.
  • Interest participating in an online program to improve eating and physical activity.
  • Regular access to the internet.
  • Comfort with using the internet and navigating websites.
  • Living in Utah or neighboring counties.
  • Have not participated in other web/mobile or self-help book studies from the USU CBS lab.

You may not qualify if:

  • We will recommend participants consult their physician if they have a condition that might be affected by changes to diet or exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

April 15, 2019

First Posted

May 1, 2019

Study Start

May 28, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations