ObesityProject HealthNCT01680224
Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
A study testing Healthy Weight and Project Health in people with Obesity and Weight Gain, run by Oregon Research Institute at 4 sites in United States.
Trial summary
Obesity is a major US public health problem. Few obesity prevention programs have reduced risk for weight gain over follow-up and those that have are very intensive, making dissemination difficult and costly. Read more about this study
- Who is it for?
- Ages 17 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain, Eating Disorders
- What is being tested?
- Healthy Weight and Project Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2012to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- University student
- Presents with self-reported "weight concerns"
Who cannot join
- Diagnosis of Eating Disorder
- Obese
- Underweight
- Non-english speaking
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas, Austin
Austin, Texas, 78713
Oregon State University
Corvallis, Oregon, 97331
University of Oregon
Eugene, Oregon, 94703
Oregon Research Institute
Eugene, Oregon, 97403
About this study
Obesity is a major US public health problem. Few obesity prevention programs have reduced risk for weight gain over follow-up and those that have are very intensive, making dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy Weight) targeting young adults with body dissatisfaction involving participant-driven healthy dietary and physical activity lifestyle changes significantly reduced increases in body mass index (BMI) and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy, the investigators added dissonance-inducing activities regarding unhealthy dietary and activity practices, drawing from a highly efficacious dissonance-based eating disorder prevention program. A pilot trial found that this new Project Health intervention significantly reduced increases in BMI relative to both the Healthy Weight intervention and an educational brochure condition from pre to post. The investigators propose to conduct a rigorous multisite effectiveness trial that will test whether adding the dissonance-induction elements to the originally Healthy Weight intervention improves weight gain prevention effects. 360 college students at risk for future weight by virtue of their age and weight concerns will be randomized one of three conditions: (1) a refined 6-hr group-based dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a psychoeducational video ("Weight of the World") condition. Participants will complete assessments of % body fat, mediators (including objectively measured physical activity), moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.
Read the detailed description
Aim 1 will test the hypothesis that Project Health significantly reduces increases in % body fat relative to the Healthy Weight intervention and video control condition during a 2-yr follow-up; secondary outcomes are BMI, depressive symptoms and eating disorder symptoms. The investigators will also compare Healthy Weight to video controls.
Aim 2 will test the hypothesis that Project Health participants will experience increased cognitive dissonance (an uncomfortable psychological state) regarding eating unhealthy foods and engaging in sedentary behaviors, and that changes in dissonance mediate the program's weight gain prevention effects. The investigators will also test whether reduced calorie intake and increased physical activity mediate the effects of Project Health on change in % body fat.
Aim 3 will test the hypothesis that intervention effects are amplified for participants with elevated body dissatisfaction (which should increase motivation change) and preference for consistency (which should maximize dissonance induction) and mitigated for participants who report emotional eating and substance use (because these factors increase risk for overeating).
- Conditions
- Obesity, Weight Gain, Eating Disorders
- Being tested
- Healthy Weight, Project Health, Placebo Control
- Keywords
- Obesity, Weight Gain, Dissonance, College,University Students, Eating Disorders, Obesity Prevention, Selective Prevention, Effectiveness
- Medical subject headings
- Obesity, Weight Gain, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy WeightBehavioural
Project HealthBehavioural
Placebo ControlBehavioural
Participants will view a video on overweight and obesity
| Study group | Role | What they receive |
|---|---|---|
| Healthy Weight | Active comparator | The main goal of the Healthy Weight intervention is to make small, sustainable changes to input and output on a weekly basis to achieve a balance between caloric intake and output. All sessions begin with a brief review of what was covered in the previous session, presentation of educational handouts, careful review of previous behavior change goals, and the development of healthy behavior change plans for the next session. Home exercises for all sessions consist of following individualized diet and exercise goals, and keeping a food and exercise log to determine areas for future healthy changes. Receives: Behavioral: Healthy Weight |
| Project Health | Experimental | Project Health adds dissonance-inducing activities, discussions, and homework activities to the Healthy Weight basic intervention. Each session begins with a verbal commitment to participate (to underscore the voluntary nature of participation), includes discussions of completed home practice assignments and in-session writing/sharing exercises (to create accountability), and concludes with home exercises (to increase level of effort). Completed home assignments are videotaped in subsequent sessions to increase accountability. Receives: Behavioral: Project Health |
| Control | Placebo comparator | Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view. Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Percentage
We will use air displacement plethysmography (ADP) via the Bod Pod S/T to assess % body fat. Two measures will be averaged. Body density, calculated as body mass divided by estimated body volume, is used to calculate age- and gender-adjusted body fat percentile scores, based on normative reference data (McCarthy et al., 2006). A pilot validity study (N = 30) revealed that direct DEXA measures of % body fat correlates much more strongly with ADP estimates of body fat (r = .88) than with BMI (r = .23). Change in age- and gender-adjusted body fat percentile over the 2-year follow-up will be the primary outcome. This assessment takes 3-5 minutes to complete.
Measured: Changes in body fat from baseline to 2-year follow up
Secondary outcomes (3)
Eating Pathology
The Eating Disorder Diagnostic Interview, a brief semi-structured interview, will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder, which will allow us to exclude participants with these disorders. It also provides a continuous measure of overall eating disorder symptoms.
Measured: Baseline and post intervention (6 weeks); 6/12/24 month follow-up
Negative Affect
The 20-item Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS: Watson et al., 1988) measures general negative affectivity and depressive symptoms. Using a Likert rating system, participants choose their degree of endorsement of negative affectivity items such as "disgusted with self" and "lonely" (response options: 1 = not at all; 5 = extremely).
Measured: Baseline and post intervention (6 weeks); 6/12/24 month follow-ups
Food Craving/Liking
The 28-item Food Craving Inventory (FCI; White et al., 2002) assesses subjective cravings for individual foods (pasta, ice cream), asking: "Over the past month, how often have you experienced a craving for the food?"
Measured: Baseline, 6 weeks (post intervention), 6/12/24 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study start1 Sep 2012
- Primary completion30 Jun 2016
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (99)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Stice, PhD, Principal investigator, Oregon Research InstitutePaul Rohde, PhD, Study director, Oregon Research InstituteHeather Shaw, PhD, Study director, Oregon Research InstituteKyle Burger, PhD, Study director, Oregon Research InstituteNathan Marti, PhD, Study director, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680224
- Sponsor's protocol ID
- HD071900
- Acronym
- Project Health
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2012
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson DA, Shapiro JR, Lundgren JD. The freshman year of college as a critical period for weight gain: an initial evaluation. Eat Behav. 2003 Nov;4(4):363-7. doi: 10.1016/S1471-0153(03)00030-8.
PubMed 15000962Becker CB, Stice E, Shaw H, Woda S. Use of empirically supported interventions for psychopathology: can the participatory approach move us beyond the research-to-practice gap? Behav Res Ther. 2009 Apr;47(4):265-74. doi: 10.1016/j.brat.2009.02.007. Epub 2009 Feb 21.
PubMed 19281965van den Berg P, Neumark-Sztainer D. Fat 'n happy 5 years later: is it bad for overweight girls to like their bodies? J Adolesc Health. 2007 Oct;41(4):415-7. doi: 10.1016/j.jadohealth.2007.06.001.
PubMed 17875468Blair AJ, Lewis VJ, Booth DA. Does emotional eating interfere with success in attempts at weight control? Appetite. 1990 Oct;15(2):151-7. doi: 10.1016/0195-6663(90)90047-c.
PubMed 2268140Block G, Subar AF. Estimates of nutrient intake from a food frequency questionnaire: the 1987 National Health Interview Survey. J Am Diet Assoc. 1992 Aug;92(8):969-77.
PubMed 1640041Bohon C, Stice E, Spoor S. Female emotional eaters show abnormalities in consummatory and anticipatory food reward: a functional magnetic resonance imaging study. Int J Eat Disord. 2009 Apr;42(3):210-21. doi: 10.1002/eat.20615.
PubMed 19040270Block G, Hartman AM, Naughton D. A reduced dietary questionnaire: development and validation. Epidemiology. 1990 Jan;1(1):58-64. doi: 10.1097/00001648-199001000-00013.
PubMed 2081241Boomsma. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7, 461-483.
Boutelle KN, Hannan P, Fulkerson JA, Crow SJ, Stice E. Obesity as a prospective predictor of depression in adolescent females. Health Psychol. 2010 May;29(3):293-8. doi: 10.1037/a0018645.
PubMed 20496983Burton E, Stice E. Evaluation of a healthy-weight treatment program for bulimia nervosa: a preliminary randomized trial. Behav Res Ther. 2006 Dec;44(12):1727-38. doi: 10.1016/j.brat.2005.12.008. Epub 2006 Feb 3.
PubMed 16458252Butler SM, Black DR, Blue CL, Gretebeck RJ. Change in diet, physical activity, and body weight in female college freshman. Am J Health Behav. 2004 Jan-Feb;28(1):24-32. doi: 10.5993/ajhb.28.1.3.
PubMed 14977156Chambers WJ, Puig-Antich J, Tabrizi MA, Davies M. Psychotic symptoms in prepubertal major depressive disorder. Arch Gen Psychiatry. 1982 Aug;39(8):921-7. doi: 10.1001/archpsyc.1982.04290080037006.
PubMed 7103681Cialdini, R. B., Trost, M. R., & Newsom, J. T. (1995). Preference for consistency: The development of a valid measure and the discovery of surprising behavioral implications. J Pers Soc Psychol, 69, 318-328.
Coleman KJ, Tiller CL, Sanchez J, Heath EM, Sy O, Milliken G, Dzewaltowski DA. Prevention of the epidemic increase in child risk of overweight in low-income schools: the El Paso coordinated approach to child health. Arch Pediatr Adolesc Med. 2005 Mar;159(3):217-24. doi: 10.1001/archpedi.159.3.217.
PubMed 15753263Colley RC, Tremblay MS. Moderate and vigorous physical activity intensity cut-points for the Actical accelerometer. J Sports Sci. 2011 May;29(8):783-9. doi: 10.1080/02640414.2011.557744.
PubMed 21424979
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
- ClinicalTrials.gov ID
- NCT01680224
- Acronym / sponsor ID
- Project Health / HD071900
- Conditions
- Obesity, Weight Gain, Eating Disorders
- Keywords
- Obesity, Weight Gain, Dissonance, College,University Students, Eating Disorders, Obesity Prevention, Selective Prevention, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a major US public health problem. Few obesity prevention programs have reduced risk for weight gain over follow-up and those that have are very intensive, making dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy Weight) targeting young adults with body dissatisfaction involving participant-driven healthy dietary and physical activity lifestyle changes significantly reduced increases in body mass index (BMI) and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy, the investigators added dissonance-inducing activities regarding unhealthy dietary and activity practices, drawing from a highly efficacious dissonance-based eating disorder prevention program. A pilot trial found that this new Project Health intervention significantly reduced increases in BMI relative to both the Healthy Weight intervention and an educational brochure condition from pre to post. The investigators propose to conduct a rigorous multisite effectiveness trial that will test whether adding the dissonance-induction elements to the originally Healthy Weight intervention improves weight gain prevention effects. 360 college students at risk for future weight by virtue of their age and weight concerns will be randomized one of three conditions: (1) a refined 6-hr group-based dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a psychoeducational video ("Weight of the World") condition. Participants will complete assessments of % body fat, mediators (including objectively measured physical activity), moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.
Detailed description
Aim 1 will test the hypothesis that Project Health significantly reduces increases in % body fat relative to the Healthy Weight intervention and video control condition during a 2-yr follow-up; secondary outcomes are BMI, depressive symptoms and eating disorder symptoms. The investigators will also compare Healthy Weight to video controls.
Aim 2 will test the hypothesis that Project Health participants will experience increased cognitive dissonance (an uncomfortable psychological state) regarding eating unhealthy foods and engaging in sedentary behaviors, and that changes in dissonance mediate the program's weight gain prevention effects. The investigators will also test whether reduced calorie intake and increased physical activity mediate the effects of Project Health on change in % body fat.
Aim 3 will test the hypothesis that intervention effects are amplified for participants with elevated body dissatisfaction (which should increase motivation change) and preference for consistency (which should maximize dissonance induction) and mitigated for participants who report emotional eating and substance use (because these factors increase risk for overeating).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Weight | Active comparator | Behavioral: Healthy WeightThe main goal of the Healthy Weight intervention is to make small, sustainable changes to input and output on a weekly basis to achieve a balance between caloric intake and output. All sessions begin with a brief review of what was covered in the previous session, presentation of educational handouts, careful review of previous behavior change goals, and the development of healthy behavior change plans for the next session. Home exercises for all sessions consist of following individualized diet and exercise goals, and keeping a food and exercise log to determine areas for future healthy changes. |
| Project Health | Experimental | Behavioral: Project HealthProject Health adds dissonance-inducing activities, discussions, and homework activities to the Healthy Weight basic intervention. Each session begins with a verbal commitment to participate (to underscore the voluntary nature of participation), includes discussions of completed home practice assignments and in-session writing/sharing exercises (to create accountability), and concludes with home exercises (to increase level of effort). Completed home assignments are videotaped in subsequent sessions to increase accountability. |
| Control | Placebo comparator | Behavioral: Placebo ControlSome participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view. |
Who may qualify
- Ages
- 17 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- University student
- Presents with self-reported "weight concerns"
Key exclusion criteria (4 listed)
- Diagnosis of Eating Disorder
- Obese
- Underweight
- Non-english speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Weight | Behavioural | Healthy Weight |
| Project Health | Behavioural | Project Health |
| Placebo ControlParticipants will view a video on overweight and obesity | Behavioural | Control |
Primary outcome
Body Fat Percentage
Time frame: Changes in body fat from baseline to 2-year follow up
We will use air displacement plethysmography (ADP) via the Bod Pod S/T to assess % body fat. Two measures will be averaged. Body density, calculated as body mass divided by estimated body volume, is used to calculate age- and gender-adjusted body fat percentile scores, based on normative reference data (McCarthy et al., 2006). A pilot validity study (N = 30) revealed that direct DEXA measures of % body fat correlates much more strongly with ADP estimates of body fat (r = .88) than with BMI (r = .23). Change in age- and gender-adjusted body fat percentile over the 2-year follow-up will be the primary outcome. This assessment takes 3-5 minutes to complete.
3 secondary outcomes
Eating Pathology
Time frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-up
Negative Affect
Time frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-ups
Food Craving/Liking
Time frame: Baseline, 6 weeks (post intervention), 6/12/24 month follow ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Background: PubMed 15000962Anderson DA, Shapiro JR, Lundgren JD. The freshman year of college as a critical period for weight gain: an initial evaluation. Eat Behav. 2003 Nov;4(4):363-7. doi: 10.1016/S1471-0153(03)00030-8.
- Background: PubMed 19281965Becker CB, Stice E, Shaw H, Woda S. Use of empirically supported interventions for psychopathology: can the participatory approach move us beyond the research-to-practice gap? Behav Res Ther. 2009 Apr;47(4):265-74. doi: 10.1016/j.brat.2009.02.007. Epub 2009 Feb 21.
- Background: PubMed 17875468van den Berg P, Neumark-Sztainer D. Fat 'n happy 5 years later: is it bad for overweight girls to like their bodies? J Adolesc Health. 2007 Oct;41(4):415-7. doi: 10.1016/j.jadohealth.2007.06.001.
- Background: PubMed 2268140Blair AJ, Lewis VJ, Booth DA. Does emotional eating interfere with success in attempts at weight control? Appetite. 1990 Oct;15(2):151-7. doi: 10.1016/0195-6663(90)90047-c.
- Background: PubMed 1640041Block G, Subar AF. Estimates of nutrient intake from a food frequency questionnaire: the 1987 National Health Interview Survey. J Am Diet Assoc. 1992 Aug;92(8):969-77.
- Background: PubMed 19040270Bohon C, Stice E, Spoor S. Female emotional eaters show abnormalities in consummatory and anticipatory food reward: a functional magnetic resonance imaging study. Int J Eat Disord. 2009 Apr;42(3):210-21. doi: 10.1002/eat.20615.
- Background: PubMed 2081241Block G, Hartman AM, Naughton D. A reduced dietary questionnaire: development and validation. Epidemiology. 1990 Jan;1(1):58-64. doi: 10.1097/00001648-199001000-00013.
- BackgroundBoomsma. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7, 461-483.
- Background: PubMed 20496983Boutelle KN, Hannan P, Fulkerson JA, Crow SJ, Stice E. Obesity as a prospective predictor of depression in adolescent females. Health Psychol. 2010 May;29(3):293-8. doi: 10.1037/a0018645.
- Background: PubMed 16458252Burton E, Stice E. Evaluation of a healthy-weight treatment program for bulimia nervosa: a preliminary randomized trial. Behav Res Ther. 2006 Dec;44(12):1727-38. doi: 10.1016/j.brat.2005.12.008. Epub 2006 Feb 3.
- Background: PubMed 14977156Butler SM, Black DR, Blue CL, Gretebeck RJ. Change in diet, physical activity, and body weight in female college freshman. Am J Health Behav. 2004 Jan-Feb;28(1):24-32. doi: 10.5993/ajhb.28.1.3.
- Background: PubMed 7103681Chambers WJ, Puig-Antich J, Tabrizi MA, Davies M. Psychotic symptoms in prepubertal major depressive disorder. Arch Gen Psychiatry. 1982 Aug;39(8):921-7. doi: 10.1001/archpsyc.1982.04290080037006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Stice, PhD principal investigator
Oregon Research Institute
Paul Rohde, PhD study director
Oregon Research Institute
Heather Shaw, PhD study director
Oregon Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight and Project Health in people with Obesity and Weight Gain, run by Oregon Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Percentage (time frame: Changes in body fat from baseline to 2-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680224, which also lists 99 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.