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ObesityPROSPERNCT02990494

Prevention & Promotion in the Treatment of Obesity

A study testing STANDARD, PREVENT and PROMOTE in people with Obesity, run by The Miriam Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Show all 9Show fewer
  • 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 groups in NCT02990494
Study groupRoleWhat they receive
STANDARDActive comparator12-week Internet-delivered behavioral weight loss program
Receives: Behavioral: STANDARD
PREVENTExperimentalan enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences
Receives: Behavioral: PREVENT
PROMOTEExperimentalan 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.

  1. Change in food choice decision-making task

    Measured: baseline baseline and within 30 days of intervention conclusion

Secondary outcomes (3)
  1. 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

  2. change in cravings and consumption questionnaire

    Measured: from baseline to within 30 days of intervention conclusion

  3. 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.

  1. First posted13 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

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)
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

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.

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