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KU Alternate Meal Energy Level Study (KAMEL)

Primary Purpose

Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Portion-Controlled Meals

Low-Calorie Diet

Intermittent Very-Low Calorie Diet

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight management, obesity, very-low calorie diet, intermittent diet

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 21-65 years.
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.
Clearance for participation from their PCP.

Exclusion Criteria:

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.
Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34].
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
Unwilling to be randomized to one of two diet strategies for weight loss.
Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
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.
Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
Medications known to significantly influence weight.
Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Calorie Restriction

Intermittent Very-Low Calorie Diet

Arm Description

Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals

Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days

Outcomes

Primary Outcome Measures

Weight (lbs, % change from baseline)

Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)

Body composition

Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks

Secondary Outcome Measures

Program adherence

Compliance to intervention protocol; adherence = (# attained / # expected)*100

Nutrition-related quality of life

Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.

Dietary restraint

Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)

Full Information

NCT ID

NCT03696966

First Posted

September 26, 2018

Last Updated

January 18, 2019

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03696966

Brief Title

KU Alternate Meal Energy Level Study

Acronym

KAMEL

Official Title

KU Alternate Meal Energy Level Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 16, 2018 (Actual)

Primary Completion Date

October 4, 2018 (Actual)

Study Completion Date

November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Weight Loss

Keywords

weight management, obesity, very-low calorie diet, intermittent diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Calorie Restriction

Arm Type

Active Comparator

Arm Description

Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals

Arm Title

Intermittent Very-Low Calorie Diet

Arm Type

Experimental

Arm Description

Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days

Intervention Type

Dietary Supplement

Intervention Name(s)

Portion-Controlled Meals

Intervention Description

Increase dietary structure using portion-controlled meals (PCM)

Intervention Type

Behavioral

Intervention Name(s)

Low-Calorie Diet

Intervention Description

Restrict calorie intake daily

Intervention Type

Behavioral

Intervention Name(s)

Intermittent Very-Low Calorie Diet

Other Intervention Name(s)

Intermittent Fasting

Intervention Description

Severely restrict calorie intake intermittently

Primary Outcome Measure Information:

Title

Weight (lbs, % change from baseline)

Description

Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)

Time Frame

Change from baseline to 24 weeks

Title

Body composition

Description

Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks

Time Frame

Change from baseline to 24 weeks

Secondary Outcome Measure Information:

Title

Program adherence

Description

Compliance to intervention protocol; adherence = (# attained / # expected)*100

Time Frame

weekly through study completion (24 weeks)

Title

Nutrition-related quality of life

Description

Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.

Time Frame

baseline, week 12, week 24

Title

Dietary restraint

Description

Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)

Time Frame

baseline, week 12, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21-65 years. 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. Clearance for participation from their PCP. Exclusion Criteria: 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. Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34]. 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 Unwilling to be randomized to one of two diet strategies for weight loss. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation. 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. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study. Medications known to significantly influence weight. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.) Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.). If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra Sullivan, PhD, RD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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KU Alternate Meal Energy Level Study

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