ObesityPROSPERNCT02990494
Prevention & Promotion in the Treatment of Obesity
A study testing STANDARD, PREVENT and PROMOTE in people with Obesity, run by The Miriam Hospital.
Trial summary
Making healthy food choices requires sacrificing immediate pleasures of consuming high calorie foods in order to achieve long-term health goals. Two strategies to encourage such future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods, and 2) focusing on the long-term benefits of… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- STANDARD, PREVENT and PROMOTE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jun 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 25-60
- currently overweight or obese (BMI 25-45 kg/m2)
Who cannot join
- lack of access to a computer and the Internet (needed once per week),
- weight loss medications
- neurological or psychiatric conditions including but not limited to schizophrenia, and bipolar disorder
- inability to attend assessments
- lack of interest in participating in a behavioral weight loss trial
- serious current physical disease for which physician supervision of diet and exercise prescription is needed
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- physical problems that limit the ability to exercise
- participation in a weight loss program within the last 2 months
- intention to become pregnant in the next 3 months
About this study
Making healthy food choices requires sacrificing immediate pleasures of consuming high calorie foods in order to achieve long-term health goals. Two strategies to encourage such future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods, and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel behavioral weight loss (BWL) interventions will be developed based on these strategies (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their feasibility and efficacy in changing food choice decision-making, reducing food cravings, and ultimate weight loss.
Read the detailed description
Obesity is one of the most important public health issues today, contributing to many of the primary causes of morbidity and mortality in the United States. Still, treatment remains difficult and many people continually struggle to lose weight. Thus there is critical need for improvements in methods for treating obesity. One potential reason weight control is so difficult is the need to sacrifice immediate pleasures for long-term goals. This requires placing significant value on future outcomes, such as health.
One strategy for doing so is to focus on the potential benefits of avoiding unhealthy choices. Health messaging studies suggest that messages focused on promoting long-term benefits of healthier choices may be effective in encouraging initiation of, or positive attitudes toward, healthy behaviors, however, longer-term effects of these messages have not been studied in the context of obesity. By contrast, behavioral economic work on Prospect Theory suggests focusing on preventing future negative consequences may be superior, and the threat of weight gain is a more powerful motivator than the benefit of weight loss. Although prevention strategies have been successfully employed in smoking cessation and anti-smoking campaigns, they are not typically used in obesity treatment. In promising preliminary neuroimaging work, the investigators identified increases in brain regions involved in inhibitory control and decreases in cravings when using this PREVENT strategy.
The goal of this R03 is to test whether an intervention built upon the goal to PREVENT long-term consequences of weight gain versus an intervention built upon the goal to PROMOTE long-term benefits of weight loss is beneficial in altering valuation of health and taste in food choice decision-making, encouraging adherence, reducing food cravings and consumption, and ultimate weight loss, as compared to a standard behavioral weight loss program (BWL). A total of 90 overweight/obese men and women will be randomly assigned to either PREVENT, PROMOTE, or standard BWL. Each intervention will have one in-person training session wherein participants will learn key strategies of their assigned program, and the remaining 12 weekly lessons will be delivered via internet. Baseline and 3-month (post-treatment) assessments will include the food choice decision-making task featured in the parent K01 to measure valuation of health and taste, weight measurement, and measurement of food cravings and consumption. To address feasibility, adherence and engagement measures (i.e., lessons viewed, self-monitoring) will be collected during the internet program, and memory for lesson content will be assessed post-treatment. Individual difference measures will also be collected to provide preliminary data on factors that may influence success in each arm.
This project tests innovative approaches in the clinical treatment of obesity and will provide new insights into the potential role of prevention versus promotion strategies for weight loss.
- Conditions
- Obesity
- Being tested
- STANDARD, PREVENT, PROMOTE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARDBehavioural
Also called Standard Internet-delivered behavioral weight loss
Standard Internet-delivered behavioral weight loss
PREVENTBehavioural
Also called PREVENT Internet-delivered behavioral weight loss
enhanced standard Internet-delivered behavioral weight loss program
PROMOTEBehavioural
Also called PROMOTE Internet-delivered behavioral weight loss
enhanced standard Internet-delivered behavioral weight loss program
| Study group | Role | What they receive |
|---|---|---|
| STANDARD | Active comparator | 12-week Internet-delivered behavioral weight loss program Receives: Behavioral: STANDARD |
| PREVENT | Experimental | an enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences Receives: Behavioral: PREVENT |
| PROMOTE | Experimental | an enhanced 12-week Internet-delivered behavioral weight loss program focused on promoting future benefits Receives: Behavioral: PROMOTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food choice decision-making task
Measured: baseline baseline and within 30 days of intervention conclusion
Secondary outcomes (3)
adherence and acceptability questionnaire
assessing adherence (number of lessons viewed and self-monitoring data entered by participants) throughout the intervention and acceptability of the intervention following treatment
Measured: during 12-week intervention and within 30 days of intervention conclusion
change in cravings and consumption questionnaire
Measured: from baseline to within 30 days of intervention conclusion
change in scale-measured body weight
Measured: from baseline to within 30 days of intervention conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn E. Demos, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990494
- Sponsor's protocol ID
- 1R03DK106405-01A1
- Acronym
- PROSPER
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention & Promotion in the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT02990494
- Acronym / sponsor ID
- PROSPER / 1R03DK106405-01A1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Dec 2016 (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.
Making healthy food choices requires sacrificing immediate pleasures of consuming high calorie foods in order to achieve long-term health goals. Two strategies to encourage such future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods, and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel behavioral weight loss (BWL) interventions will be developed based on these strategies (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their feasibility and efficacy in changing food choice decision-making, reducing food cravings, and ultimate weight loss.
Detailed description
Obesity is one of the most important public health issues today, contributing to many of the primary causes of morbidity and mortality in the United States. Still, treatment remains difficult and many people continually struggle to lose weight. Thus there is critical need for improvements in methods for treating obesity. One potential reason weight control is so difficult is the need to sacrifice immediate pleasures for long-term goals. This requires placing significant value on future outcomes, such as health.
One strategy for doing so is to focus on the potential benefits of avoiding unhealthy choices. Health messaging studies suggest that messages focused on promoting long-term benefits of healthier choices may be effective in encouraging initiation of, or positive attitudes toward, healthy behaviors, however, longer-term effects of these messages have not been studied in the context of obesity. By contrast, behavioral economic work on Prospect Theory suggests focusing on preventing future negative consequences may be superior, and the threat of weight gain is a more powerful motivator than the benefit of weight loss. Although prevention strategies have been successfully employed in smoking cessation and anti-smoking campaigns, they are not typically used in obesity treatment. In promising preliminary neuroimaging work, the investigators identified increases in brain regions involved in inhibitory control and decreases in cravings when using this PREVENT strategy.
The goal of this R03 is to test whether an intervention built upon the goal to PREVENT long-term consequences of weight gain versus an intervention built upon the goal to PROMOTE long-term benefits of weight loss is beneficial in altering valuation of health and taste in food choice decision-making, encouraging adherence, reducing food cravings and consumption, and ultimate weight loss, as compared to a standard behavioral weight loss program (BWL). A total of 90 overweight/obese men and women will be randomly assigned to either PREVENT, PROMOTE, or standard BWL. Each intervention will have one in-person training session wherein participants will learn key strategies of their assigned program, and the remaining 12 weekly lessons will be delivered via internet. Baseline and 3-month (post-treatment) assessments will include the food choice decision-making task featured in the parent K01 to measure valuation of health and taste, weight measurement, and measurement of food cravings and consumption. To address feasibility, adherence and engagement measures (i.e., lessons viewed, self-monitoring) will be collected during the internet program, and memory for lesson content will be assessed post-treatment. Individual difference measures will also be collected to provide preliminary data on factors that may influence success in each arm.
This project tests innovative approaches in the clinical treatment of obesity and will provide new insights into the potential role of prevention versus promotion strategies for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STANDARD | Active comparator | Behavioral: STANDARD12-week Internet-delivered behavioral weight loss program |
| PREVENT | Experimental | Behavioral: PREVENTan enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences |
| PROMOTE | Experimental | Behavioral: PROMOTEan enhanced 12-week Internet-delivered behavioral weight loss program focused on promoting future benefits |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ages 25-60
- currently overweight or obese (BMI 25-45 kg/m2)
Key exclusion criteria (9 listed)
- lack of access to a computer and the Internet (needed once per week),
- weight loss medications
- neurological or psychiatric conditions including but not limited to schizophrenia, and bipolar disorder
- inability to attend assessments
- lack of interest in participating in a behavioral weight loss trial
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 |
|---|---|---|
| STANDARDAlso: Standard Internet-delivered behavioral weight lossStandard Internet-delivered behavioral weight loss | Behavioural | STANDARD |
| PREVENTAlso: PREVENT Internet-delivered behavioral weight lossenhanced standard Internet-delivered behavioral weight loss program | Behavioural | PREVENT |
| PROMOTEAlso: PROMOTE Internet-delivered behavioral weight lossenhanced standard Internet-delivered behavioral weight loss program | Behavioural | PROMOTE |
Primary outcome
Change in food choice decision-making task
Time frame: baseline baseline and within 30 days of intervention conclusion
3 secondary outcomes
adherence and acceptability questionnaire
Time frame: during 12-week intervention and within 30 days of intervention conclusion
change in cravings and consumption questionnaire
Time frame: from baseline to within 30 days of intervention conclusion
change in scale-measured body weight
Time frame: from baseline to within 30 days of intervention conclusion
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 15 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD, PREVENT and PROMOTE in people with Obesity, run by The Miriam Hospital.
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 9 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in food choice decision-making task (time frame: baseline baseline and within 30 days of intervention conclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2018.