ObesityPrimaryCareNCT00455780
Weight Loss Maintenance in Primary Care
A study testing Weight Loss Phase, Continued CBT and reduced energy density education in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial summary
After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Weight Loss Phase, Continued CBT and reduced energy density education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of 30, or BMI of 27 with weight-related comorbidities
- Access to a telephone and voice mail/answering machine
- MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)
Who cannot join
- Previously/currently diagnosed with an eating disorder
- Current bi-polar, depression, substance abuse, or dependence disorder
- Living with someone already enrolled
- Enrolled in another weight loss program
- Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
- Myocardial infraction within the past three months
Show all 11Show fewer
- Unstable angina
- Nephrotic syndrome/malabsorptive disease
- Gout attack within the past year
- Lactating/pregnant (or planning within next two years)
- Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.
- Conditions
- Obesity, Overweight
- Being tested
- Weight Loss Phase, Continued CBT, reduced energy density education, continued use of meal replacements
- Keywords
- Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss PhaseBehavioural
Weight loss using CBT and meal replacements
Continued CBTBehavioural
Using CBT during weight loss maintenance
reduced energy density educationBehavioural
Additional nutritional learning
continued use of meal replacementsBehavioural
continued use of meal replacements during weight loss maintenance
| Study group | Role | What they receive |
|---|---|---|
| MR-/REDE- | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance. Receives: Behavioral: Weight Loss Phase; Behavioral: Continued CBT |
| MR+/REDE- | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance. Receives: Behavioral: Weight Loss Phase; Behavioral: Continued CBT; Behavioral: continued use of meal replacements |
| MR-/REDE+ | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance. Receives: Behavioral: Weight Loss Phase; Behavioral: Continued CBT; Behavioral: reduced energy density education |
| MR+/REDE+ | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance. Receives: Behavioral: Weight Loss Phase; Behavioral: Continued CBT; Behavioral: reduced energy density education; Behavioral: continued use of meal replacements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: baseline, 3 months, 12 months, 24 months, 36 months
Secondary outcomes (3)
Body composition
Measured: baseline, 3 months, 12 months, 24 months, 36 months
Blood work results
Measured: baseline, 3 months, 12 months, 24 months
Scores on questionnaire-based measures
Measured: baseline, 3 months, 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJan 2005
- Primary completionAug 2010
- Study completionAug 2010
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Investigators
- Michael R Lowe, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455780
- Sponsor's protocol ID
- DK66759 (completed)
- Other IDs
- R01DK066759
- Acronym
- PrimaryCare
- Status last verified
- May 2011
- First submitted
- 3 Apr 2007
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Maintenance in Primary Care
- ClinicalTrials.gov ID
- NCT00455780
- Acronym / sponsor ID
- PrimaryCare / DK66759 (completed)
- Conditions
- Obesity, Overweight
- Keywords
- Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Apr 2007 (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.
After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MR-/REDE- | Experimental | Behavioral: Weight Loss Phase, Behavioral: Continued CBTWeight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance. |
| MR+/REDE- | Experimental | Behavioral: Weight Loss Phase, Behavioral: Continued CBT, Behavioral: continued use of meal replacementsWeight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance. |
| MR-/REDE+ | Experimental | Behavioral: Weight Loss Phase, Behavioral: Continued CBT, Behavioral: reduced energy density educationWeight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance. |
| MR+/REDE+ | Experimental | Behavioral: Weight Loss Phase, Behavioral: Continued CBT, Behavioral: reduced energy density education, Behavioral: continued use of meal replacementsWeight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI of 30, or BMI of 27 with weight-related comorbidities
- Access to a telephone and voice mail/answering machine
- MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)
Key exclusion criteria (11 listed)
- Previously/currently diagnosed with an eating disorder
- Current bi-polar, depression, substance abuse, or dependence disorder
- Living with someone already enrolled
- Enrolled in another weight loss program
- Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
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 PhaseWeight loss using CBT and meal replacements | Behavioural | MR+/REDE+, MR+/REDE-, MR-/REDE+, MR-/REDE- |
| Continued CBTUsing CBT during weight loss maintenance | Behavioural | MR+/REDE+, MR+/REDE-, MR-/REDE+, MR-/REDE- |
| reduced energy density educationAdditional nutritional learning | Behavioural | MR+/REDE+, MR-/REDE+ |
| continued use of meal replacementscontinued use of meal replacements during weight loss maintenance | Behavioural | MR+/REDE+, MR+/REDE- |
Primary outcome
Weight
Time frame: baseline, 3 months, 12 months, 24 months, 36 months
3 secondary outcomes
Body composition
Time frame: baseline, 3 months, 12 months, 24 months, 36 months
Blood work results
Time frame: baseline, 3 months, 12 months, 24 months
Scores on questionnaire-based measures
Time frame: baseline, 3 months, 12 months, 24 months, 36 months
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 25 May 2011.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Michael R Lowe, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Phase, Continued CBT and reduced energy density education in people with Obesity and Overweight, run by Drexel University 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 3 inclusion and 11 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 25 May 2011. 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?
Weight (time frame: baseline, 3 months, 12 months, 24 months, 36 months). 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 25 May 2011.