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CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss (CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736669
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gareth R. Dutton PhD, University of Alabama at Birmingham

Brief Summary:
This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Energy Reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fixed Energy (or Calorie) Reduction
Participants randomly assigned to this arm will be instructed to reduce their food intake by a moderate amount and stay at this level of moderate reduction until their weight loss goal is achieved.
Behavioral: Energy Reduction
Experimental: Variable Energy (or Calorie) Reduction
Participants randomly assigned to this arm will be instructed to alternate between two levels of calorie reduction. One level will be a small amount of calorie reduction, while the other will be a more significant amount of calorie reduction. At the instruction of the research team, participants will periodically alternate back and forth between these two goals until their weight loss goal is achieved.
Behavioral: Energy Reduction



Primary Outcome Measures :
  1. Body weight [ Time Frame: 6, 12, and 18 months ]
    change in body weight (kg) from baseline to follow-up assessments


Secondary Outcome Measures :
  1. Resting energy expenditure [ Time Frame: 6, 12, and 18 months ]
    An indirect calorimeter with the ventilated hood technique will be used for the 30-minute measurement (the first 10 minutes will be excluded from analysis). The respiratory quotient will be calculated as the ratio of carbon dioxide production to oxygen consumption. Resting metabolic rate will be calculated from VO2 and VCO2 measurements using the Weir equation.

  2. Body composition [ Time Frame: 6, 12, and 18 months ]
    Assessed by full body DXA scan to evaluate percentage of body fat.

  3. Laboratory analyses [ Time Frame: 6, 12, and 18 months ]
    Glucose, lipids, and insulin will be analyzed using blood samples.

  4. Blood pressure [ Time Frame: 6, 12, and 18 months ]
    After a 5 minute seated rest, three measurements using an automated blood pressure device will be taken to obtain the average systolic and diastolic blood pressures.

  5. Hormones - ghrelin [ Time Frame: 6, 12, and 18 months ]
    Total ghrelin will be assessed using blood samples.

  6. Hormones - leptin [ Time Frame: 6, 12, and 18 months ]
    Total leptin will be assessed using blood samples.

  7. Satiety/hunger [ Time Frame: 6, 12, and 18 months ]
    Visual analogue scales (VAS) will be used to measure subjective ratings of appetite. Participants will be asked to provide a rating in response to several questions (e.g., "How hungry did you feel this week? How much did you think about food this week?") using a 100-mm line ranging from "not at all" to "extremely".

  8. Energy intake [ Time Frame: Daily ]
    Participants will be encouraged to utilize web-based and mobile apps for dietary self-monitoring. Energy intake (kcal/day) will be calculated for all daily entries that include at least two eating episodes, defined as the entry of food item(s) and corresponding caloric values. Daily self-monitoring of energy intake will occur up to 365 days between baseline and month 12 time points.

  9. Physical activity - objective [ Time Frame: 6, 12, and 18 months ]
    Will be assessed via accelerometers worn by participants for seven days. Participants will be instructed to position the accelerometer at the right hip and to wear the device throughout the day except when sleeping, bathing, or participating in swimming or other water activities. These data will be used to estimate total minutes of moderate- to vigorous-intensity PA.

  10. Physical activity - self-report [ Time Frame: 6, 12, and 18 months ]
    Self-reported PA will also be assessed with the Paffenbarger Physical Activity Questionnaire (PPAQ). Both methods of PA measurement are included, as accelerometers provide objective information about total levels of activity, while the PPAQ provides additional details about the type and schedule of activities.

  11. Treatment adherence [ Time Frame: 6, 12, and 18 months ]
    Treatment adherence will be assessed by the number of treatment sessions attended as well as the number of self-monitoring forms completed, which have both been used as indicators of adherence in our previous work

  12. Treatment novelty [ Time Frame: 6, 12, and 18 months ]
    This construct will be evaluated with a 6-item measure of treatment reinforcement that assesses the extent to which participants enjoy and become less habituated to the behavioral strategies required for weight loss.

  13. Treatment burden [ Time Frame: 6, 12, and 18 months ]
    Behavioral burden of treatment will be assessed with a modified version of the Treatment Burden Questionnaire (TBQ), which includes 15 items measuring the burden of treatment, including behaviors of self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.

  14. Treatment satisfaction [ Time Frame: 6, 12, and 18 months ]
    Participants will complete a modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) to assess attitudes and satisfaction regarding the weight loss intervention, energy prescriptions provided, and weight loss achieved. A composite score of treatment satisfaction will be calculated based on participants' responses.

  15. Side effects [ Time Frame: 6, 12, and 18 months ]
    Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with both treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21-75
  • Body mass index (BMI) 30-50 kg/m2

Exclusion Criteria:

  • Uncontrolled hypertension (blood pressure >160/100 mm Hg)
  • Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
  • Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
  • Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
  • Likely to relocate out of the area in the next 2 years
  • Participation in another randomized research project
  • Weight loss > 10 pounds in past six months
  • History of bariatric surgery
  • Major depressive or psychiatric disorder, or excessive alcohol intake
  • Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
  • Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736669


Locations
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United States, Alabama
University of Alabama at Birmingham, Medical Towers Building
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Gareth R Dutton, PhD University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine

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Responsible Party: Gareth R. Dutton PhD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02736669    
Other Study ID Numbers: R01DK103863 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
Keywords provided by Gareth R. Dutton PhD, University of Alabama at Birmingham:
weight loss
body weight
behavioral
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms