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

Obesity Clinical Trial

— CARE  

Official title:

Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02736669
• Other study ID #: R01DK103863
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 223
• Est. completion date: March 2024
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Energy Reduction

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham, Medical Towers Building	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	change in body weight (kg) from baseline to follow-up assessments	6, 12, and 18 months
Secondary	Resting energy expenditure	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.	6, 12, and 18 months
Secondary	Body composition	Assessed by full body DXA scan to evaluate percentage of body fat.	6, 12, and 18 months
Secondary	Laboratory analyses	Glucose, lipids, and insulin will be analyzed using blood samples.	6, 12, and 18 months
Secondary	Blood pressure	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.	6, 12, and 18 months
Secondary	Hormones - ghrelin	Total ghrelin will be assessed using blood samples.	6, 12, and 18 months
Secondary	Hormones - leptin	Total leptin will be assessed using blood samples.	6, 12, and 18 months
Secondary	Satiety/hunger	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".	6, 12, and 18 months
Secondary	Energy intake	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.	Daily
Secondary	Physical activity - objective	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.	6, 12, and 18 months
Secondary	Physical activity - self-report	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.	6, 12, and 18 months
Secondary	Treatment adherence	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	6, 12, and 18 months
Secondary	Treatment novelty	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.	6, 12, and 18 months
Secondary	Treatment burden	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.	6, 12, and 18 months
Secondary	Treatment satisfaction	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.	6, 12, and 18 months
Secondary	Side effects	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.	6, 12, and 18 months