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Evaluation of the ACT on Health Program

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ClinicalTrials.gov Identifier: NCT03932994
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Levin, Utah State University

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. 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. 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.

If successful, this project will both provide an ongoing canvas extension course delivered throughout Utah to improve health behaviors.

This project seeks to develop and test an online, self-guided ACT program (ACT on Health) to improve diet and physical activity. ACT on Health will include 8 weekly modules teaching effective health behavior change methods coupled with ACT strategies to reduce maladaptive motivators and enhance adaptive motivators for change. The investigators will evaluate the program in a RCT relative to a waitlist condition with 60 overweight/obese adults recruited through Extension in 7 Utah counties. The program will be offered through the USU Extension Canvas platform to ensure, if effective, that the program could continue to be offered across Utah.

The two hypotheses for this study are as follows:

  1. Participants will report a high degree of satisfaction and will demonstrate adequate engagement in the ACT on Health program.
  2. Participants assigned to ACT on Health will improve more on self-reported diet, physical activity, and quality of life relative to the waitlist condition.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: ACT on Health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Evaluation of ACT on Health: An Online Health Promotion Program
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Arm Intervention/treatment
Experimental: ACT on Health Intervention
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
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.

No Intervention: Waitlist
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.



Primary Outcome Measures :
  1. Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) [ Time Frame: 24 hours ]
    Asks participants to report on the specific foods they ate over the past day to measure specific nutritional intake


Secondary Outcome Measures :
  1. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 1 week ]
    Measures types and length of physical activity performed in the last week. The questionnaire can be scored using the number of minutes spent doing physical activity or by categorizing into low (less physical activity reported than the specified amounts for medium or high physical activity), medium (at least half an hour of at least moderate physical activity on most days), and high physical activity (1 hour or more of at least moderate physical activity per day).

  2. Three Factor Eating Questionnaire (TFEQ) [ Time Frame: 8 weeks ]
    Measures dietary restraint, disinhibited eating, and predisposition to hunger. The TFEQ has three subscales: dietary restraint (ranging from 0-21), disinhibition (ranging from 0-16), and hunger (ranging from 0-14). Greater scores indicate greater dietary restraint, disinhibition, and hunger.

  3. Weight Control Strategies Scale (WCSS) [ Time Frame: 8 weeks ]
    Measures use of specific behaviors thought to help weight loss. This scale has four subscales: Dietary Choices (10 items, ranging from 0-40), Self-monitoring Strategies (7 items, ranging from 0-28), Physical Activity (6 items, ranging from 0-24), and Psychological Coping (7 items, ranging from 0-28). The total score can range from 0-120. Scores are established by adding up all items. Greater scores mean greater use of weight control strategies as specified by the subscales.

  4. General Health Questionnaire (GHQ) General Health Questionnaire [ Time Frame: 2 weeks ]
    Measure of psychological morbidity and general distress. The total score can range from 12-28, with higher scores indicating greater psychological health.

  5. Weight Self Stigma Questionnaire (WSSQ) [ Time Frame: During the past month ]
    Measures self-devaluation and fear of enacted stigma in overweight individuals. There are two subscales, self-devaluation and fear of enacted stigma, added together to form the total score. The total scores range from 12-60, with higher scores indicating greater weight self stigma. The subscale scores both range from 6-30 with higher scores indicating greater self-devaluation and fear of enacted stigma.

  6. Acceptance and Action Questionnaire for Weight-Related Difficulties (AAQ-W) [ Time Frame: 8 weeks ]
    Measures experiential avoidance of weight-related thoughts, feelings, and experiences.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No other exclusion criteria will be used in order to ensure a representative sample and to maximize participant flow
  • We will recommend participants consult their physician if they have a condition that might be affected by changes to diet or exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932994


Locations
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United States, Utah
Utah State University
Logan, Utah, United States, 84322
Sponsors and Collaborators
Utah State University
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Responsible Party: Michael Levin, Associate Professor, Utah State University
ClinicalTrials.gov Identifier: NCT03932994    
Other Study ID Numbers: AOH2018
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight