KU Alternate Meal Energy Level Study

Obesity Clinical Trial

— KAMEL  

Official title:

KU Alternate Meal Energy Level Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696966
• Other study ID #: IRB_STUDY00141322
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: January 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.

Description:

The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.

Each intervention includes 3 months of weight loss and 3 months of weight maintenance.

Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)

Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 1, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 21-65 years.

2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI >35 may require more aggressive weight management strategies.

3. Clearance for participation from their PCP.

Exclusion Criteria:

1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.

2. Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34].

3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire

4. Unwilling to be randomized to one of two diet strategies for weight loss.

5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.

6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.

7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater [35]. This score indicates the need for counseling outside the scope of this study.

8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.

9. Medications known to significantly influence weight.

10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)

11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).

12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Portion-Controlled Meals
Increase dietary structure using portion-controlled meals (PCM)

Behavioral:
• Low-Calorie Diet
Restrict calorie intake daily
• Intermittent Very-Low Calorie Diet
Severely restrict calorie intake intermittently

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (lbs, % change from baseline)	Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)	Change from baseline to 24 weeks
Primary	Body composition	Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks	Change from baseline to 24 weeks
Secondary	Program adherence	Compliance to intervention protocol; adherence = (# attained / # expected)*100	weekly through study completion (24 weeks)
Secondary	Nutrition-related quality of life	Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.	baseline, week 12, week 24
Secondary	Dietary restraint	Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)	baseline, week 12, week 24