Overweight and ObesityNCT03560635
Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity
A study of Overweight and Obesity and Weight Loss Maintenance, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Overweight and Obesity, Weight Loss Maintenance, Dietary Habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 25 Jan 2022
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ethnic groups and both genders
- Age: 21-70 years
- BMI: 18.5-40 kg/m2
- Weight loss of >10% body mass achieved within 4 weeks of enrollment in study.
Who cannot join
- Uncontrolled cardio metabolic disease such as: cardiovascular disease (CVD), diabetes mellitus, hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly, following established guidelines), renal disease (e.g. chronic kidney disease, polycystic kidney disease, nephritis, etc.), hepatic disease (e.g. cirrhosis, liver failure, fatty liver, jaundice, etc.), untreated thyroid disease (e.g. Grave's disease, Hashimoto's disorder, goiters, thyroid cancers, etc.), or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If these conditions become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
- Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
- Significant gastrointestinal disorders including: inflammatory bowel disease requiring treatment within the past year, chronic malabsorptive conditions, chronic diarrhea, or active gallbladder disease.
- Use of pharmacotherapy agents to achieve weight loss prior to study enrollment.
- Current treatment with medications known to significantly affect appetite, weight, energy metabolism, energy intake or energy expenditure. (e.g. systemic corticosteroids, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
- History of surgical or endoscopic procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve, intragastric balloons, aspiration therapy, etc); history of extensive bowel resection for other reasons.
Show all 15Show fewer
- Currently pregnant, lactating or less than 6 months post-partum.
- Planning to become pregnant during study enrollment period
- Self-report of alcohol or substance abuse within the past 12 months.
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder, or score >20 on the EATS-26. Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation.
- Major psychiatric disorder (e.g. diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders).
- Current severe depression or history of severe depression within the previous year (based on reported history, study physician examination findings, and/or a score >21 on the CES-D). Participants meeting any of these criteria will be referred to their primary care physician and/or the emergency department (based upon study physician determined level of severity).
- Currently participating in or planning to participate in any formal weight loss programs or clinical trials.
- Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
- Unable or unwilling to undergo study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks. Eligible participants will have lost >10% body mass. The reverse diet group will receive personalized caloric intake goals, increasing 2-3%/week. The CON group will receive standard weight maintenance recommendations with matched contact. At baseline and week 12, resting energy expenditure (REE), body mass and composition, subjective appetite, and food intake behaviors will be evaluated. In addition to the pre- and post-intervention measures, body mass and adherence to reverse diet will be monitored weekly.
- Being tested
- Weight Loss Maintenance (Control vs. Reverse Diet)
- Keywords
- weight loss maintenance, reverse diet, body composition, metabolic rate, dietary adherence, resting energy expenditure, weight loss, weight regain
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Maintenance (Control vs. Reverse Diet)Behavioural
Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program. This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll. While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period. Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease. The informational handouts will be provided to participants, but not specifically covered in weekly meetings. Groups will differ only in specific caloric prescriptions (described in the Arms section).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants randomized to the CON condition will be informed of their estimated weight maintenance calorie needs (determined by multiplying their resting energy expenditure (REE) obtained from indirect calorimetry by an appropriate activity factor and advised to adhere to this calorie target, as is standard weight maintenance advice. Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the diet protocol. Receives: Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet) |
| Reverse Diet | Experimental | Participants randomized to the reverse diet condition will receive specific caloric intake goals. The initial caloric goal will be set at 2-3% above the level participants ended their weight loss diet at (via self-report). Participants' caloric goals will increase at a rate of 2-3% per week. Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the reverse diet protocol. Receives: Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the prescribed diet
Self-reported caloric intake compared to prescribed caloric intake
Measured: 12 weeks
Adherence to the prescribed diet
Evaluated via mathematical model based on change in body mass and composition.
Measured: 12 weeks
Enrollment Success
The investigators will assess whether they are able to enroll 24 participants meeting study inclusion/exclusion criteria over a 9-month recruitment window. If enrollment is <24, the investigators will determine barriers to enrollment and re-evaluate the study design and/or recruitment strategies. The investigators will also assess participation rate (number approached versus enrolled), reasons potential participants decline enrollment, and ability to meet demographic goals for the larger trial (approximately equal men and women, ≥33% racial and ethnic minorities).
Measured: 9 months
Attrition Rate
The investigators will assess the participant drop-out rate and reasons for attrition over the 12-week study, determine reasons for drop-outs and examine whether drop-out rates differ between intervention arms.
Measured: 12 Months
Secondary outcomes (8)
Changes in Body Mass
Measured via calibrated digital scale.
Measured: Measured weekly throughout the 12-week trial.
Changes in Body Composition
Measured via Dual-energy X-ray absorptiometry (DXA) scan
Measured: At baseline and post intervention (Week 12).
Changes in Resting Energy Expenditure
Measured via standard indirect calorimetry with ventilated hood technique
Measured: At baseline and post intervention (Week 12).
Dietary Adherence
Evaluated via self-report using a measure created by researchers:
- "How adherent were you to the prescribed diet over the past week?",
- measured by self-report from 1 (not at all) to 10 (very much so),
- higher scores indicate higher dietary adherence
Measured: Measured weekly throughout the 12-week trial.
Effort
Measure created by researchers:
- "How hard was it to adhere to the prescribed diet over the last week?"
- measured by self-report from 1(very easy) to 10 (very difficult)
- higher scores indicate more expended effort
Measured: Weekly, throughout the 12-Week Trial
Self-Efficacy
Measure created by researchers:
- "How likely do you feel you can adhere to the prescribed diet for the next week?"
- measured by self-report from 1(not at all likely) to 10 (very likely)
- higher scores indicate higher self-efficacy
Measured: Weekly, throughout the 12-Week Trial
Changes in Food-Related Behaviors
Evaluated via Three-Factor Eating Questionnaire, which is divided into three subscales:
- Factor One: Dietary Restraint (higher scores indicate higher levels of restrained eating)
- Factor Two: Dis-inhibition of Control (higher scores indicate higher levels of disinhibited eating)
- Factor Three: Susceptibility to Hunger (higher scores indicate higher levels of predisposition to hunger)
Measured: At baseline and post intervention (Week 12).
Changes in Food-Related Behaviors
Evaluated via the Weight Efficacy Lifestyle Questionnaire, which is divided into five subscales:
- Negative Emotions
- Availability
- Social Pressure
- Physical Discomfort
- Positive Activities
Measured: At baseline and post intervention (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start14 Feb 2018
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya Halliday, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560635
- Sponsor's protocol ID
- 17-1726
- Status last verified
- Apr 2022
- First submitted
- 21 May 2018
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT03560635
- Acronym / sponsor ID
- 17-1726
- Keywords
- weight loss maintenance, reverse diet, body composition, metabolic rate, dietary adherence, resting energy expenditure, weight loss, weight regain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks. Eligible participants will have lost >10% body mass. The reverse diet group will receive personalized caloric intake goals, increasing 2-3%/week. The CON group will receive standard weight maintenance recommendations with matched contact. At baseline and week 12, resting energy expenditure (REE), body mass and composition, subjective appetite, and food intake behaviors will be evaluated. In addition to the pre- and post-intervention measures, body mass and adherence to reverse diet will be monitored weekly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet)Participants randomized to the CON condition will be informed of their estimated weight maintenance calorie needs (determined by multiplying their resting energy expenditure (REE) obtained from indirect calorimetry by an appropriate activity factor and advised to adhere to this calorie target, as is standard weight maintenance advice. Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the diet protocol. |
| Reverse Diet | Experimental | Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet)Participants randomized to the reverse diet condition will receive specific caloric intake goals. The initial caloric goal will be set at 2-3% above the level participants ended their weight loss diet at (via self-report). Participants' caloric goals will increase at a rate of 2-3% per week. Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the reverse diet protocol. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All ethnic groups and both genders
- Age: 21-70 years
- BMI: 18.5-40 kg/m2
- Weight loss of >10% body mass achieved within 4 weeks of enrollment in study.
Key exclusion criteria (15 listed)
- Uncontrolled cardio metabolic disease such as: cardiovascular disease (CVD), diabetes mellitus, hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly, following established guidelines), renal disease (e.g. chronic kidney disease, polycystic kidney disease, nephritis, etc.), hepatic disease (e.g. cirrhosis, liver failure, fatty liver, jaundice, etc.), untreated thyroid disease (e.g. Grave's disease, Hashimoto's disorder, goiters, thyroid cancers, etc.), or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If these conditions become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
- Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
- Significant gastrointestinal disorders including: inflammatory bowel disease requiring treatment within the past year, chronic malabsorptive conditions, chronic diarrhea, or active gallbladder disease.
- Use of pharmacotherapy agents to achieve weight loss prior to study enrollment.
- Current treatment with medications known to significantly affect appetite, weight, energy metabolism, energy intake or energy expenditure. (e.g. systemic corticosteroids, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
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 |
|---|---|---|
| Weight Loss Maintenance (Control vs. Reverse Diet)Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program. This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll. While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period. Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease. The informational handouts will be provided to participants, but not specifically covered in weekly meetings. Groups will differ only in specific caloric prescriptions (described in the Arms section). | Behavioural | Control, Reverse Diet |
Primary outcome
Adherence to the prescribed diet
Time frame: 12 weeks
Self-reported caloric intake compared to prescribed caloric intake
Adherence to the prescribed diet
Time frame: 12 weeks
Evaluated via mathematical model based on change in body mass and composition.
Enrollment Success
Time frame: 9 months
The investigators will assess whether they are able to enroll 24 participants meeting study inclusion/exclusion criteria over a 9-month recruitment window. If enrollment is <24, the investigators will determine barriers to enrollment and re-evaluate the study design and/or recruitment strategies. The investigators will also assess participation rate (number approached versus enrolled), reasons potential participants decline enrollment, and ability to meet demographic goals for the larger trial (approximately equal men and women, ≥33% racial and ethnic minorities).
Attrition Rate
Time frame: 12 Months
The investigators will assess the participant drop-out rate and reasons for attrition over the 12-week study, determine reasons for drop-outs and examine whether drop-out rates differ between intervention arms.
8 secondary outcomes
Changes in Body Mass
Time frame: Measured weekly throughout the 12-week trial.
Changes in Body Composition
Time frame: At baseline and post intervention (Week 12).
Changes in Resting Energy Expenditure
Time frame: At baseline and post intervention (Week 12).
Dietary Adherence
Time frame: Measured weekly throughout the 12-week trial.
Effort
Time frame: Weekly, throughout the 12-Week Trial
Self-Efficacy
Time frame: Weekly, throughout the 12-Week Trial
Changes in Food-Related Behaviors
Time frame: At baseline and post intervention (Week 12).
Changes in Food-Related Behaviors
Time frame: At baseline and post intervention (Week 12).
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 19 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Tanya Halliday, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight and Obesity and Weight Loss Maintenance, run by University of Colorado, Denver at 1 site 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 4 inclusion and 15 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Adherence to the prescribed diet (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 19 Apr 2022.