CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss (CARE)
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|ClinicalTrials.gov Identifier: NCT02736669|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Energy Reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Body weight [ Time Frame: 6, 12, and 18 months ]change in body weight (kg) from baseline to follow-up assessments
- 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.
- Body composition [ Time Frame: 6, 12, and 18 months ]Assessed by full body DXA scan to evaluate percentage of body fat.
- Laboratory analyses [ Time Frame: 6, 12, and 18 months ]Glucose, lipids, and insulin will be analyzed using blood samples.
- 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.
- Hormones - ghrelin [ Time Frame: 6, 12, and 18 months ]Total ghrelin will be assessed using blood samples.
- Hormones - leptin [ Time Frame: 6, 12, and 18 months ]Total leptin will be assessed using blood samples.
- 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".
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham, Medical Towers Building|
|Birmingham, Alabama, United States, 35205|
|Principal Investigator:||Gareth R Dutton, PhD||University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine|