Comparing Diet and Exercise Approaches in Women

NCT ID: NCT04372771

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-19
• Study Completion Date: 2012-03-22

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.

Conditions

Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Control

No diet or exercise intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Curves Program

The Curves group will follow the high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 7-days at 1,200 kcals/day and then 1,500 kcals/day for the remaining 21-days of the 30-day diet period. The participants will then consume a normal maintenance diet (2,200 kcals/d; 45% carbohydrate, 30% protein, 25% fat) for 30-days. During the maintenance period, participants will diet for 2-days at 1,200 kcals/day if they gain 3 pounds of weight.

Group Type: EXPERIMENTAL

Curves Circuit

Intervention Type: OTHER

The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups. These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.

Weight Watchers Momentum Program

This program is based on the Weight Watchers four pillar approach (food, exercise, behavior and support). The Momentum Program uses POINTS values to help keep track of what you eat. A POINTS "budget" will be personalized for you at the weekly meetings.

Group Type: EXPERIMENTAL

Weight Watchers

Intervention Type: OTHER

The Weight Watchers program encourages one to increase physical activity.

Interventions

Curves Circuit

The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups. These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.

Intervention Type: OTHER

Weight Watchers

The Weight Watchers program encourages one to increase physical activity.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Richard B. Kreider

Executive Director, Human Clinical Research Facility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

References

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.

Reference Type: DERIVED

PMID: 35457744 (View on PubMed)

Other Identifiers

IRB2010-0130F

Identifier Type: -

Identifier Source: org_study_id