Comparing Diet and Exercise Approaches in Women

NCT04372771 | Completed DMC

• 1 other identifier: IRB2010-0130F
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diet Modification

Keywords

Exercise Intervention

Outcome Measures

Primary Outcomes (5)

• Body Composition: Body Weight

  Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

• Body Composition: Fat Mass

  Changes in body composition (lbs. fat mass) obtained via Dual-Energy X-Ray Absorptiometry (DXA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

• Body Composition: Lean Mass

  Changes in body composition (lbs. lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

• Body Composition: Percent Body Fat

  Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

• Energy Homeostasis: Resting Energy Expenditure (REE)

  Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

Secondary Outcomes (25)

• Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press

  Measured prior to supplementation (Pre), and after 16 weeks

• Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press

  Measured prior to supplementation (Pre), and after 16 weeks

• Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test

  Measured prior to supplementation (Pre), and after 16 weeks

• Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test

  Measured prior to supplementation (Pre), and after 16 weeks

• Lipid Panel: Cholesterol

  Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

Study Arms (3)

Control

NO INTERVENTION

No diet or exercise intervention

Curves Program

EXPERIMENTAL

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.

Other: Curves Circuit

Weight Watchers Momentum Program

EXPERIMENTAL

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.

Other: Weight Watchers

Interventions

Curves Circuit 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.

Curves Program

Weight Watchers OTHER

The Weight Watchers program encourages one to increase physical activity.

Weight Watchers Momentum Program

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Texas A&M University: lead

Related Publications (1)

• 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.

  PMID: 35457744 DERIVED

Study Officials

• Richard B Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Human Clinical Research Facility

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: April 19, 2010
• Primary Completion: March 22, 2012
• Study Completion: March 22, 2012
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share