Diet ModificationCWWNCT04372771
Comparing Diet and Exercise Approaches in Women
A study testing Curves Circuit and Weight Watchers in people with Diet Modification, run by Texas A&M University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Curves Circuit and Weight Watchers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2010to 22 Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is female
- Participant is between the ages of 18 and 45
- Participant is sedentary and overweight (BMI > 27)
Who cannot join
- 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).
About this study
Official title: Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women
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.
Read the 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
- Being tested
- Curves Circuit, Weight Watchers
- Keywords
- Exercise Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curves CircuitOther
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 WatchersOther
The Weight Watchers program encourages one to increase physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Weight Watchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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
Changes in bench press 1 Repetition Maximum (1RM) obtained from a bench press test 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: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Changes in leg press 1RM obtained from a leg press test 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: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Changes in total repetitions at 80% of 1RM obtained from a bench press test 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: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Changes in total repetitions at 80% of 1RM obtained from a leg press test 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: Measured prior to supplementation (Pre), and after 16 weeks
Lipid Panel: Cholesterol
Changes in cholesterol obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: HDL Cholesterol
Changes in HDL cholesterol obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: LDL Cholesterol
Changes in LDL cholesterol obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Triglycerides
Changes in triglycerides obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Cholesterol:HDL Ratio
Changes in cholesterol to HDL cholesterol ratio obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Comprehensive Metabolic Panel (CMP): Glucose
Changes in glucose obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Insulin
Changes in insulin obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Leptin
Changes in leptin obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
Changes in HOMA-IR obtained via venous blood draws 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Heart Rate (HR)
Changes in resting heart rate (HR) obtained via a blood pressure meter 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Changes in resting systolic blood pressure (SBP) obtained via a blood pressure meter 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
Changes in resting diastolic blood pressure (DBP) obtained via a blood pressure meter 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist Circumference
Changes in waist circumference obtained via tape measure 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Hip Circumference
Changes in hip circumference obtained via tape measure 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: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist to Hip Ratio
Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Exercise Capacity: Peak Exercise Capacity (VO2)
Changes in exercise capacity (VO2 max) obtained via a treadmill test 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: Measured prior to supplementation (Pre), and after 16 weeks
Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Changes in exercise capacity (time to peak VO2 max) obtained via a treadmill test 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: Measured prior to supplementation (Pre), and after 16 weeks
Dietary Energy Intake: Total Caloric Intake (kcals/d)
Changes in caloric/energy intake (kcals/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Carbohydrate
Changes in dietary carbohydrate intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Fat
Changes in dietary fat intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Protein
Changes in dietary protein intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start19 Apr 2010
- Primary completion22 Mar 2012
- Study completion22 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard B. Kreider, Texas A&M University
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372771
- Sponsor's protocol ID
- IRB2010-0130F
- Acronym
- CWW
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35457744
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women
- ClinicalTrials.gov ID
- NCT04372771
- Acronym / sponsor ID
- CWW / IRB2010-0130F
- Conditions
- Diet Modification
- Keywords
- Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 19 Apr 2010 (actual)
- Primary completion
- 22 Mar 2012 (actual)
- Study completion
- 22 Mar 2012 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No diet or exercise intervention |
| Curves Program | Experimental | Other: Curves CircuitThe 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. |
| Weight Watchers Momentum Program | Experimental | Other: Weight WatchersThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant is female
- Participant is between the ages of 18 and 45
- Participant is sedentary and overweight (BMI > 27)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curves CircuitThe 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. | Other | Curves Program |
| Weight WatchersThe Weight Watchers program encourages one to increase physical activity. | Other | Weight Watchers Momentum Program |
Primary outcome
Body Composition: Body Weight
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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)
Body Composition: Fat Mass
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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)
Body Composition: Lean Mass
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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)
Body Composition: Percent Body Fat
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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)
Energy Homeostasis: Resting Energy Expenditure (REE)
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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)
25 secondary outcomes
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Lipid Panel: Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: HDL Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: LDL Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Triglycerides
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Cholesterol:HDL Ratio
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Comprehensive Metabolic Panel (CMP): Glucose
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Insulin
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Leptin
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Heart Rate (HR)
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist Circumference
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Hip Circumference
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist to Hip Ratio
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Exercise Capacity: Peak Exercise Capacity (VO2)
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Time frame: Measured prior to supplementation (Pre), and after 16 weeks
Dietary Energy Intake: Total Caloric Intake (kcals/d)
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Carbohydrate
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Fat
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Protein
Time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 35457744Lockard 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.
- Individual participant dataSharing planned: No
Related trials for Diet Modification
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Endometriosis
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing Curves Circuit and Weight Watchers in people with Diet Modification, run by Texas A&M University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition: Body Weight (time frame: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.