OverweightNCT01065974
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
A study testing Behavior Therapy, Meal Replacements and Nutritrol in people with Overweight and Obesity, run by Drexel University at 2 sites in United States.
Trial summary
The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity, Weight Loss Maintenance
- What is being tested?
- Behavior Therapy, Meal Replacements and Nutritrol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to 30 Apr 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants between the ages of 18 and 65
- body mass index (BMI; kg/m2) between 27-45
- able to travel regularly to the study location
- interested in participating in a weight loss program.
Who cannot join
- currently enrolled in another organized weight loss program
- lactose intolerance
- taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
- history of gastric bypass or other surgical weight loss procedures
- medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
- pregnancy or planning to become pregnant during the next two years -
- breastfeeding
- consuming an amount of alcohol that could interfere with study completion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Drexel University
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.
- Conditions
- Overweight, Obesity, Weight Loss Maintenance
- Being tested
- Behavior Therapy, Meal Replacements, Nutritrol
- Keywords
- Nutritional Intake, Psychosocial Outcome
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
Weight loss using CBT and continued CBT during weight loss maintenance.
Meal ReplacementsDietary supplement
Weight loss using CBT and meal replacements.
NutritrolBehavioural
To make widespread nutritional changes to participants personal food environments.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy | Active comparator | Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below:
* Self monitoring
* Stimulus control
* Changing eating behaviors
* Goal setting
* Problem solving
* Social support
* Cognitive restructuring
* Relapse prevention Receives: Behavioral: Behavior Therapy |
| Behavior Therapy + Meal Replacements | Experimental | The BT +MR condition will implement behavioral treatment strategies in a way that is nearly identical to that of the BT condition. However, participants in this condition also will use MRs during weight loss and weight loss maintenance. Receives: Dietary Supplement: Meal Replacements |
| Nutritrol | Experimental | Participants in this condition will be informed about the evidence indicating that the availability, structure and composition of foods they encounter or seek out in their daily lives will play a major role in determining their ability to maintain the weight they lose. We will present the treatment as an opportunity to make numerous changes to their "personal food environment" involving the variety, energy density, nutritional composition, and portion size of the foods they encounter in every day life.
The Nutritrol condition is comprised of several components:
* Food structure
* Energy density
* Reduce variety of foods high in energy density and increase variety of foods low in energy density
* Protein intake
* Controlling the personal food environment
* Individualized weight loss maintenance prescriptions Receives: Behavioral: Nutritrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body weight over time.
Change in body weight measured on electronic scale.
Measured: Baseline, 6 months, 12 months, 18 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 posted10 Feb 2010 (estimated)
- Study startOct 2009
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Michael Lowe, Drexel University
- Investigators
- Michael R Lowe, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065974
- Sponsor's protocol ID
- 5R01DK80909-2
- Other IDs
- 5R01DK080909
- Status last verified
- Oct 2017
- First submitted
- 8 Feb 2010
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. 2018 Jan 1;107(1):12-19. doi: 10.1093/ajcn/nqx005.
PubMed 29381791Feig EH, Lowe MR. Variability in Weight Change Early in Behavioral Weight Loss Treatment: Theoretical and Clinical Implications. Obesity (Silver Spring). 2017 Sep;25(9):1509-1515. doi: 10.1002/oby.21925.
PubMed 28845608
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT01065974
- Acronym / sponsor ID
- 5R01DK80909-2
- Conditions
- Overweight, Obesity, Weight Loss Maintenance
- Keywords
- Nutritional Intake, Psychosocial Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Oct 2009
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 10 Feb 2010 (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.
The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy | Active comparator | Behavioral: Behavior TherapyBehavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below: * Self monitoring * Stimulus control * Changing eating behaviors * Goal setting * Problem solving * Social support * Cognitive restructuring * Relapse prevention |
| Behavior Therapy + Meal Replacements | Experimental | Dietary Supplement: Meal ReplacementsThe BT +MR condition will implement behavioral treatment strategies in a way that is nearly identical to that of the BT condition. However, participants in this condition also will use MRs during weight loss and weight loss maintenance. |
| Nutritrol | Experimental | Behavioral: NutritrolParticipants in this condition will be informed about the evidence indicating that the availability, structure and composition of foods they encounter or seek out in their daily lives will play a major role in determining their ability to maintain the weight they lose. We will present the treatment as an opportunity to make numerous changes to their "personal food environment" involving the variety, energy density, nutritional composition, and portion size of the foods they encounter in every day life. The Nutritrol condition is comprised of several components: * Food structure * Energy density * Reduce variety of foods high in energy density and increase variety of foods low in energy density * Protein intake * Controlling the personal food environment * Individualized weight loss maintenance prescriptions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants between the ages of 18 and 65
- body mass index (BMI; kg/m2) between 27-45
- able to travel regularly to the study location
- interested in participating in a weight loss program.
Key exclusion criteria (8 listed)
- currently enrolled in another organized weight loss program
- lactose intolerance
- taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
- history of gastric bypass or other surgical weight loss procedures
- medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
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 |
|---|---|---|
| Behavior TherapyWeight loss using CBT and continued CBT during weight loss maintenance. | Behavioural | Behavior Therapy |
| Meal ReplacementsWeight loss using CBT and meal replacements. | Dietary supplement | Behavior Therapy + Meal Replacements |
| NutritrolTo make widespread nutritional changes to participants personal food environments. | Behavioural | Nutritrol |
Primary outcome
Change in Body weight over time.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Change in body weight measured on electronic scale.
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 9 Oct 2017.
- Derived from this study: PubMed 29381791Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. 2018 Jan 1;107(1):12-19. doi: 10.1093/ajcn/nqx005.
- Derived from this study: PubMed 28845608Feig EH, Lowe MR. Variability in Weight Change Early in Behavioral Weight Loss Treatment: Theoretical and Clinical Implications. Obesity (Silver Spring). 2017 Sep;25(9):1509-1515. doi: 10.1002/oby.21925.
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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.
Michael R Lowe, Ph.D. principal investigator
Drexel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Therapy, Meal Replacements and Nutritrol in people with Overweight and Obesity, run by Drexel University at 2 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 4 inclusion and 8 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Body weight over time. (time frame: Baseline, 6 months, 12 months, 18 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?
On the ClinicalTrials.gov record for NCT01065974, which also lists 2 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 9 Oct 2017.