Clinical trial NCT04372771: Comparing Diet and Exercise Approaches in Women
Official title: Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: Exercise Intervention
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.

Detailed description: The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise and Sport Nutrition Lab at Texas A\&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. The Weight Watchers program is another popular weight loss program. It provides a systematic approach to diet and exercise throughout the weight-loss process. Consequently we are interested in comparing the efficacy of both programs to one another. The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.

Eligibility criteria: Inclusion Criteria:

* Participant is female
* Participant is between the ages of 18 and 45
* Participant is sedentary and overweight (BMI \> 27)

Exclusion Criteria:

* Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism;
* Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
* Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
* Participant has been pregnant or lactating within the past 12 months or are planning to become pregnant during the next 12 months;
* Participant is involved in a planned exercise program (\> 30 min./d. 3 d./wk.) within 3 - 6 months prior to the start of the study;
* Participant has taken any weight loss medications and/or dietary supplements that may affect muscle mass or body weight during the three month time period prior to beginning the study;
* Participant has a recent history of weight change (+/- 7 lbs. within the last 3 months).

Primary outcomes:
measure: Body Composition: Body Weight
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Body Composition: Fat Mass
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Body Composition: Lean Mass
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Body Composition: Percent Body Fat
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Energy Homeostasis: Resting Energy Expenditure (REE)
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Secondary outcomes:
measure: Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Lipid Panel: Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Lipid Panel: HDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Lipid Panel: LDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Lipid Panel: Triglycerides
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Lipid Panel: Cholesterol:HDL Ratio
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Comprehensive Metabolic Panel (CMP): Glucose
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Hormones: Insulin
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Hormones: Leptin
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Hemodynamic Variable: Resting Heart Rate (HR)
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Anthropometric Measures: Waist Circumference
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Anthropometric Measures: Hip Circumference
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Anthropometric Measures: Waist to Hip Ratio
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Exercise Capacity: Peak Exercise Capacity (VO2)
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
timeFrame: Measured prior to supplementation (Pre), and after 16 weeks
measure: Dietary Energy Intake: Total Caloric Intake (kcals/d)
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Dietary Energy Intake: Carbohydrate
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Dietary Energy Intake: Fat
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
measure: Dietary Energy Intake: Protein
timeFrame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lockard B, Mardock M, Oliver JM, Byrd M, Simbo S, Jagim AR, Kresta J, Baetge CC, Jung YP, Koozehchian MS, Khanna D, Rasmussen C, Kreider RB. Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women. Int J Environ Res Public Health. 2022 Apr 17;19(8):4877. doi: 10.3390/ijerph19084877.