OverweightCHOICESNCT02136290
Prepackaged Foods to Promote Weight Loss
A study testing Prepackaged meals in people with Overweight and Obese, run by University of California, San Diego at 2 sites in United States.
Trial summary
The primary goal of this clinical trial is to examine whether provision of portion-controlled prepackaged foods in the context of a reduced-energy diet prescription and counseling is associated with a greater degree of weight loss at three months in overweight or obese men and women, compared to usual care or control… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Prepackaged meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Mar 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight or obese men and women
- Aged 25-65 years
- initial BMI >27.0 kg/m2 and < 40 kg/m2
- no eating disorders, food allergies or intolerances
- no history of bariatric surgery
- willing and able to participate in clinic visits and study interactions at specified intervals
Show all 9Show fewer
- maintain contact with the investigators for at least three months
- willing to allow blood collections
- capable of performing a simple test for assessing cardiopulmonary fitness
Who cannot join
- inability to participate in physical activity because of co-morbidity or disability (e.g., severe arthritic conditions);
- a history or presence of a comorbid disease for which diet modification and increased physical activity may be contraindicated or complicated;
- self-reported pregnancy or breastfeeding or planning a pregnancy within the next two years;
- currently actively involved in another diet intervention study or organized weight loss program;
- a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego, Moores Cancer Center
La Jolla, California, 92093
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss - CHOICES Study.
The primary goal of this clinical trial is to examine whether provision of portion-controlled prepackaged foods in the context of a reduced-energy diet prescription and counseling is associated with a greater degree of weight loss at three months in overweight or obese men and women, compared to usual care or control conditions in which the prescribed reduced-energy diet is to be consumed via self-selected foods. The effect on body weight and recognized indicators of disease risk, diet quality and cardiopulmonary fitness, as well as meal satiety and satisfaction, will also be examined. Participants are 184 overweight or obese men and women in San Diego area who will be randomly assigned to usual care or control conditions.
Read the detailed description
The first study aim is (1) to test, in a randomized controlled trial, whether provision of portion-controlled prepackaged lunch and dinner entrees in the context of a reduced-energy diet prescription and counseling is associated with a greater degree of weight loss at 12 weeks in overweight or obese men and women, compared to usual care or control conditions in which the prescribed reduced-energy diet is to be consumed via self-selected foods. This study utilizes a randomized study design with participants assigned to the prepackaged food intervention arms or a usual care control group. The second study aim is (2) to describe the effect of participation in the prepackaged food arms (versus control conditions) on circulating lipids (fasting total plasma cholesterol and triglycerides, low-density lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol), carotenoids (a biomarker of vegetable and fruit intake), C-reactive protein, and cardiopulmonary fitness.
Secondary aims of this study are (3) to describe the association between prepackaged food consumption on meal satiety, eating attitudes and behavior, and meal satisfaction. The hypothesis to be tested is that eating a reduced-energy diet that incorporates unit-defined, prepackaged foods is associated with meal satiety and satisfaction that is superior to a diet based on self-selected foods.
As an exploratory aim, we also will examine whether there is a differential response to different dietary macronutrient composition in the prepackaged food items used in the structured meal plan in intervention participants. Lean Cuisine meal products will be offered to participants assigned to one intervention group, and only Lean Cuisine items with protein contributing >25% energy will be offered to participants in the other intervention group.
Notably, the results of this study may contribute valuable data to the scientific knowledge base regarding the various aspects of diet and diet composition that may promote more successful weight loss. How diet can be best modified to promote weight loss is an important issue currently being considered and debated among clinical and community-based behavioral and nutritional scientists, and the optimal composition for weight loss diets has not been established (IOM 2002). Adherence to any dietary regimen and energy imbalance is a central determinant of successful weight loss, and evidence-based approaches that may promote better adherence with less deprivation and more meal satisfaction could help public health and clinical efforts to reduce the high prevalence of overweight and obesity in the U.S. today.
- Conditions
- Overweight, Obese
- Being tested
- Prepackaged meals, Usual Care
- Keywords
- Weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepackaged mealsBehavioural
Portion-controlled prepackaged meals
Usual CareBehavioural
Usual care dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Weight loss counseling Receives: Behavioral: Usual Care |
| Prepackaged meal | Experimental | Prepackaged meals Receives: Behavioral: Prepackaged meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl L Rock, PhD, RD, Principal investigator, UC San Diego Moores Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136290
- Sponsor's protocol ID
- 140047
- Other IDs
- Nestle
- Acronym
- CHOICES
- Status last verified
- Aug 2015
- First submitted
- 8 Jan 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss - CHOICES Study.
- ClinicalTrials.gov ID
- NCT02136290
- Acronym / sponsor ID
- CHOICES / 140047
- Conditions
- Overweight, Obese
- Keywords
- Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 May 2014 (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 primary goal of this clinical trial is to examine whether provision of portion-controlled prepackaged foods in the context of a reduced-energy diet prescription and counseling is associated with a greater degree of weight loss at three months in overweight or obese men and women, compared to usual care or control conditions in which the prescribed reduced-energy diet is to be consumed via self-selected foods. The effect on body weight and recognized indicators of disease risk, diet quality and cardiopulmonary fitness, as well as meal satiety and satisfaction, will also be examined. Participants are 184 overweight or obese men and women in San Diego area who will be randomly assigned to usual care or control conditions.
Detailed description
The first study aim is (1) to test, in a randomized controlled trial, whether provision of portion-controlled prepackaged lunch and dinner entrees in the context of a reduced-energy diet prescription and counseling is associated with a greater degree of weight loss at 12 weeks in overweight or obese men and women, compared to usual care or control conditions in which the prescribed reduced-energy diet is to be consumed via self-selected foods. This study utilizes a randomized study design with participants assigned to the prepackaged food intervention arms or a usual care control group. The second study aim is (2) to describe the effect of participation in the prepackaged food arms (versus control conditions) on circulating lipids (fasting total plasma cholesterol and triglycerides, low-density lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol), carotenoids (a biomarker of vegetable and fruit intake), C-reactive protein, and cardiopulmonary fitness.
Secondary aims of this study are (3) to describe the association between prepackaged food consumption on meal satiety, eating attitudes and behavior, and meal satisfaction. The hypothesis to be tested is that eating a reduced-energy diet that incorporates unit-defined, prepackaged foods is associated with meal satiety and satisfaction that is superior to a diet based on self-selected foods.
As an exploratory aim, we also will examine whether there is a differential response to different dietary macronutrient composition in the prepackaged food items used in the structured meal plan in intervention participants. Lean Cuisine meal products will be offered to participants assigned to one intervention group, and only Lean Cuisine items with protein contributing >25% energy will be offered to participants in the other intervention group.
Notably, the results of this study may contribute valuable data to the scientific knowledge base regarding the various aspects of diet and diet composition that may promote more successful weight loss. How diet can be best modified to promote weight loss is an important issue currently being considered and debated among clinical and community-based behavioral and nutritional scientists, and the optimal composition for weight loss diets has not been established (IOM 2002). Adherence to any dietary regimen and energy imbalance is a central determinant of successful weight loss, and evidence-based approaches that may promote better adherence with less deprivation and more meal satisfaction could help public health and clinical efforts to reduce the high prevalence of overweight and obesity in the U.S. today.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Behavioral: Usual CareWeight loss counseling |
| Prepackaged meal | Experimental | Behavioral: Prepackaged mealsPrepackaged meals |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- overweight or obese men and women
- Aged 25-65 years
- initial BMI >27.0 kg/m2 and < 40 kg/m2
- no eating disorders, food allergies or intolerances
- no history of bariatric surgery
Key exclusion criteria (5 listed)
- inability to participate in physical activity because of co-morbidity or disability (e.g., severe arthritic conditions);
- a history or presence of a comorbid disease for which diet modification and increased physical activity may be contraindicated or complicated;
- self-reported pregnancy or breastfeeding or planning a pregnancy within the next two years;
- currently actively involved in another diet intervention study or organized weight loss program;
- a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the 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 |
|---|---|---|
| Prepackaged mealsPortion-controlled prepackaged meals | Behavioural | Prepackaged meal |
| Usual CareUsual care dietary counseling | Behavioural | Usual Care |
Primary outcome
Weight loss
Time frame: 3 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 21 Aug 2015.
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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.
Cheryl L Rock, PhD, RD principal investigator
UC San Diego Moores Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepackaged meals in people with Overweight and Obese, run by University of California, San Diego 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 9 inclusion and 5 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 21 Aug 2015. 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?
Weight loss (time frame: 3 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 21 Aug 2015.