OverweightNCT01345500
UCSD Take Charge Study
A study testing Higher Carbohydrate, Lower Fat Diet, Lower carbohydrate, Higher fat diet and Individualized Counseling in people with Overweight and Obese, run by University of California, San Diego at 2 sites in United States.
Trial summary
The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese, Obesity
- What is being tested?
- Higher Carbohydrate, Lower Fat Diet, Lower carbohydrate, Higher fat diet and Individualized Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Oct 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Type 2 diabetes
- BMI 25-45 kg/m2
- Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period
- Able to comply with all required study procedures and schedule
- Must live within the San Diego or Minneapolis area
Who cannot join
- Pregnant, breastfeeding or planning to become pregnant in the next year
- Serious medical condition or psychiatric illness
- History of having an eating disorder, food allergy or food intolerance
- Have food restrictions or requires a special diet
- Objects to frozen, processed or prepackaged foods
- Inability to be moderately physically active
Show all 13Show fewer
- Currently enrolled in a weight loss program or another diet intervention
- Current use of weight loss medication or supplements
- Planned surgical procedure that can impact the conduct of the study
- Previous surgical procedures for weight reduction
- Does not have own transportation
- Have plans to relocate from area within 1 year
- HbA1C >11%, fasting triglycerides >600 mg/dL, serum creatinine >1.4 mg/dL (women) or 1.5 mg/dL (men) -- to be screened at baseline visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego
La Jolla, California, 92093-0901
HealthPartners Research Foundation and University of Minnesota
Minneapolis, Minnesota
About this study
Official title: Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).
- Conditions
- Overweight, Obese, Obesity, Diabetic, Type 2 Diabetes
- Being tested
- Higher Carbohydrate, Lower Fat Diet, Lower carbohydrate, Higher fat diet, Individualized Counseling
- Keywords
- Overweight, Obese, Type 2 Diabetic, Diabetes, Weight loss, Physical activity, Diet, Prepackaged meals
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Carbohydrate, Lower Fat DietOther
Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower fat, higher carbohydrate diet provides 60% energy from carbohydrate, 20% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
Lower carbohydrate, Higher fat dietOther
Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower carbohydrate, higher fat diet provides 45% energy from carbohydrate, 35% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
Individualized CounselingOther
Participants assigned to the usual care group will be provided consultation with a research staff dietetics professional, who will provide publicly available print material that describes dietary and physical activity guidelines to promote weight loss and maintenance, at baseline (after randomization) and again at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Higher Carbohydrate/Lower Fat Diet | Experimental | Not described Receives: Other: Higher Carbohydrate, Lower Fat Diet |
| Lower Carbohydrate/Higher Fat Diet | Experimental | Not described Receives: Other: Lower carbohydrate, Higher fat diet |
| Individualized Counseling | Active comparator | Not described Receives: Other: Individualized Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss
To test, in a randomized controlled trial, whether participation in a commercial weight loss program promotes greater weight loss and weight loss maintenance at one year in overweight or obese men and women with type 2 diabetes compared to usual care conditions.
Measured: 1 year
Secondary outcomes (2)
Response to macronutrient composition
To examine whether there is a differential weight loss response at 3, 6 and/or 12 months to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher fat) in the weight loss intervention in these overweight or obese men and women with type 2 diabetes.
Measured: 1 year
Biochemical/social outcomes
To describe the effect of participating in the program (vs. usual care) on markers of glycemic control, cardiovascular disease risk, cardiopulmonary fitness, plasma carotenoids, quality of life, and eating attitudes and behaviors. Also to examine whether there is a differential response to different dietary macronutrient composition in the two weight loss intervention groups in selected metabolic factors, lipids and CRP at 6 and 12 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute, University of Minnesota
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl L Rock, PhD, RD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345500
- Sponsor's protocol ID
- 110463
- Status last verified
- Nov 2013
- First submitted
- 28 Apr 2011
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rock CL, Flatt SW, Pakiz B, Taylor KS, Leone AF, Brelje K, Heath DD, Quintana EL, Sherwood NE. Weight loss, glycemic control, and cardiovascular disease risk factors in response to differential diet composition in a weight loss program in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1573-80. doi: 10.2337/dc13-2900. Epub 2014 Apr 23.
PubMed 24760261
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01345500
- Acronym / sponsor ID
- 110463
- Conditions
- Overweight, Obese, Obesity, Diabetic, Type 2 Diabetes
- Keywords
- Overweight, Obese, Type 2 Diabetic, Diabetes, Weight loss, Physical activity, Diet, Prepackaged meals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- HealthPartners Institute, University of Minnesota
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 May 2011 (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 the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Higher Carbohydrate/Lower Fat Diet | Experimental | Other: Higher Carbohydrate, Lower Fat Diet |
| Lower Carbohydrate/Higher Fat Diet | Experimental | Other: Lower carbohydrate, Higher fat diet |
| Individualized Counseling | Active comparator | Other: Individualized Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Type 2 diabetes
- BMI 25-45 kg/m2
- Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period
- Able to comply with all required study procedures and schedule
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding or planning to become pregnant in the next year
- Serious medical condition or psychiatric illness
- History of having an eating disorder, food allergy or food intolerance
- Have food restrictions or requires a special diet
- Objects to frozen, processed or prepackaged foods
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 |
|---|---|---|
| Higher Carbohydrate, Lower Fat DietStudy participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower fat, higher carbohydrate diet provides 60% energy from carbohydrate, 20% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations. | Other | Higher Carbohydrate/Lower Fat Diet |
| Lower carbohydrate, Higher fat dietStudy participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower carbohydrate, higher fat diet provides 45% energy from carbohydrate, 35% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations. | Other | Lower Carbohydrate/Higher Fat Diet |
| Individualized CounselingParticipants assigned to the usual care group will be provided consultation with a research staff dietetics professional, who will provide publicly available print material that describes dietary and physical activity guidelines to promote weight loss and maintenance, at baseline (after randomization) and again at 6 months. | Other | Individualized Counseling |
Primary outcome
Total weight loss
Time frame: 1 year
To test, in a randomized controlled trial, whether participation in a commercial weight loss program promotes greater weight loss and weight loss maintenance at one year in overweight or obese men and women with type 2 diabetes compared to usual care conditions.
2 secondary outcomes
Response to macronutrient composition
Time frame: 1 year
Biochemical/social outcomes
Time frame: 1 year
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 14 Nov 2013.
- Derived from this study: PubMed 24760261Rock CL, Flatt SW, Pakiz B, Taylor KS, Leone AF, Brelje K, Heath DD, Quintana EL, Sherwood NE. Weight loss, glycemic control, and cardiovascular disease risk factors in response to differential diet composition in a weight loss program in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1573-80. doi: 10.2337/dc13-2900. Epub 2014 Apr 23.
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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
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Carbohydrate, Lower Fat Diet, Lower carbohydrate, Higher fat diet and Individualized Counseling 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 6 inclusion and 13 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 14 Nov 2013. 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?
Total weight loss (time frame: 1 year). 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 NCT01345500, which also lists 1 linked publication.
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 14 Nov 2013.