Exercise for Weight Loss
(WAX Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must not be taking: Lipid/glucose metabolism drugs
Disqualifiers: Cardiovascular disease, Diabetes, Tobacco, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Study Purpose:
The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.
Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained
Study Summary:
10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:
1. Moderate Intensity Continuous Training (MICT) exercise group
2. No exercise (control) group
Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.
Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that affect lipid or glucose metabolism, or if you take anti-coagulant medications.
What data supports the effectiveness of the treatment MICT Exercise for weight loss?
Research shows that exercise, including moderate-intensity continuous training (MICT), can help reduce epicardial adipose tissue (a type of fat around the heart) and support cardiovascular health in people with overweight or obesity. While exercise alone often leads to modest weight loss, combining it with dietary changes can enhance weight loss results.
12345Is moderate-intensity continuous training (MICT) safe for humans?
Research on moderate-intensity continuous training (MICT) generally shows it is safe for humans, including those who are overweight or obese. Studies have focused on its effects on heart health and weight loss, and no significant safety concerns have been reported.
26789How does the MICT exercise treatment for weight loss differ from other treatments?
The MICT exercise treatment involves moderate-intensity continuous training, which is different from high-intensity interval training (HIIT) that is often used for weight loss. MICT is a steady, moderate effort over a longer period, which may be easier for some people to maintain compared to the intense bursts of activity in HIIT.
210111213Eligibility Criteria
This trial is for premenopausal women aged 18-40 with a BMI of 30-40, who have stable weight and don't regularly exercise. It's not for those pregnant, lactating, with heart disease or metabolic diseases like diabetes, on certain medications affecting metabolism, using tobacco products, or with allergies to specific drugs.Inclusion Criteria
I am between 18 and 40 years old.
Your body mass index (BMI) is between 30 and 40.
You do not regularly engage in exercise or physical activity.
+2 more
Exclusion Criteria
You use tobacco or e-cigarettes.
You have had a bad reaction to insulin, human albumin, or potassium chloride injections before.
I have a history of heart disease, diabetes, or another metabolic condition.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
10% Weight Loss
Participants undergo a 10% weight loss program with or without exercise training, depending on group randomization. Metabolic tests are conducted before, at midpoint, and after the weight loss program.
4-7 months
Multiple visits for metabolic testing
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up testing is conducted at 2-, 4-, and 6-months post-weight loss.
6 months
3 visits (in-person) at 2-, 4-, and 6-months
Participant Groups
The study tests how adding moderate intensity continuous training (MICT) exercise affects fat tissue and metabolic health during a weight loss program compared to no exercise. Participants will undergo metabolic testing before, during and after achieving a 10% weight loss.
2Treatment groups
Experimental Treatment
Group I: No exercise (Control)Experimental Treatment1 Intervention
to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study
Group II: Moderate Intensity Continuous Training (MICT) exercise groupExperimental Treatment1 Intervention
45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Michigan School of KinesiologyAnn Arbor, MI
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
References
Effects of aerobic training with and without weight loss on insulin sensitivity and lipids. [2018]The purpose of this study is to evaluate the effect of exercise training with modest or greater weight loss (≥3%) or not (
The role of physical activity in producing and maintaining weight loss. [2022]The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss-comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose-response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed.
Physical exercise and epicardial adipose tissue: A systematic review and meta-analysis of randomized controlled trials. [2021]We performed a meta-analysis of the effects of exercise on epicardial adipose tissue (EAT). A systematic search was conducted in PubMed and Scopus (since inception to 1 February 2020) of randomized controlled trials assessing the effects of exercise interventions alone (with no concomitant weight loss intervention) on EAT. The standardized mean difference (Hedges' g) and 95% confidence interval between interventions were computed using a random effects model. Ten studies (including 521 participants who had, on average, overweight/obesity) met all inclusion criteria. Interventions were supervised and lasted 2 to 16 weeks (≥3 sessions·per week). Exercise significantly reduced EAT (g = 0.82 [0.57-1.07]) irrespective of the duration of the intervention or the EAT imaging assessment method. Exercise benefits were separately confirmed for endurance (six studies, n = 287; g = 0.83 [0.52-1.15]) but not for resistance exercise training (due to insufficient data for quantitative synthesis). It was not possible to compare the effect of high-intensity interval training (HIIT) versus moderate-intensity continuous training (two studies, one reporting higher benefits with HIIT and the other no differences). Physical exercise interventions-particularly endurance training, with further evidence needed for other exercise modalities-appear as an effective strategy for reducing EAT in individuals with overweight/obesity, which supports their implementation for cardiovascular risk reduction.
Efficacy of 10-20-30 training versus moderate-intensity continuous training on HbA1c, body composition and maximum oxygen uptake in male patients with type 2 diabetes: A randomized controlled trial. [2022]Label="AIM">To compare the efficacy of 10-20-30 training versus moderate-intensity continuous training (MICT) on HbA1c, body composition and maximum oxygen uptake (V˙O2 max) in male patients with type 2 diabetes (T2D).
Effective Weight Loss and Maintenance by Intensive Start with Diet and Exercise. [2019]This 24-month study aimed to determine whether exercise intervention added to weight loss treatment at 6 months is effective for weight loss and maintenance.
Moderate-Intensity Continuous Training Versus Moderate-Intensity Interval Training: Effects on Cardiometabolic Factors in Spanish Obese Adults. [2023]Excess weight and obesity are related to cardiometabolic diseases and limit physical activity. Until now, the effects of moderate-intensity continuous training (MICT) compared with moderate-intensity interval training (MIIT) in Spanish obese adults have not been analyzed.
Examining matched acute physiological responses to various modes of exercise in individuals who are overweight. [2016]The purpose of this study is to perform a match comparison of 3 different exercise programs: traditional continuous endurance training (ET); mixed-intensity interval ET (MI-ET); and circuit-interval resistance training (CRT) programs, to determine which of the 3 programs provides greater benefit of exercise in individuals who are overweight. This benefit of training is measured in Caloric expenditure per minute of exercise (kcalxmin), along with acute cardiovascular responses (average and maximal heart rate [HR], bxmin) and time of training spent within a favorable HR training zone for the exerciser. Thirteen (13) individuals, 7 men and 6 women, average of 35 +/- 2.3 years of age, who are overweight, average body weight of 79.8 +/- 5.1 kg with a body mass index of 35 +/- 1, were recruited from a local fitness center and were then randomly assigned to an order to complete 1 session of each of the 3 modes of exercise. There was no difference between program groups (MI-ET, CRT, and ET programs) for average HR response, p > 0.05; however, the individuals while performing the MI-ET program spent a greater percent of training time within a favorable training zone than the CRT or ET programs (p 0.05). Although the CRT produces the greatest overall Caloric expenditure, the MI-ET program produces measures that provided a significantly greater benefit of exercise for the 3 programs of interest.
Effects of HIIT and MICT on cardiovascular risk factors in adults with overweight and/or obesity: A meta-analysis. [2020]The purpose of this study was to evaluate the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on cardiovascular disease (CVD) risk factors in adults with overweight and obesity.
Moderate-Intensity Continuous Training or High-Intensity Interval Training with or without Resistance Training for Altering Body Composition in Postmenopausal Women. [2021]This study aimed to compare body composition changes induced by moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs (3 d·wk, 12 wk) in overweight/obese postmenopausal women, and to determine whether fat mass reduction is related to greater fat oxidation (FatOx).
Effectiveness of high-intensity interval training for weight loss in adults with obesity: a randomised controlled non-inferiority trial. [2022]Obesity treatment guidelines suggest moderate-intensity continuous training (MICT), but the patient's compliance to this indication remains low. High-intensity interval training (HIIT) is a time sparing training mode whose metabolic effects are not clear. This study aimed to determine whether a 12-week HIIT was more effective than MICT for weight loss in obese adults.
The effects of high-intensity interval training vs. moderate-intensity continuous training on body composition in overweight and obese adults: a systematic review and meta-analysis. [2022]The objective of this study is to compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) for improvements in body composition in overweight and obese adults.
Effect of high-intensity interval training compared to moderate-intensity continuous training on body composition and insulin sensitivity in overweight and obese adults: A systematic review and meta-analysis. [2023]To compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on adults with overweight and obesity. Outcomes, including changes in insulin sensitivity, weight, body mass index (BMI), waist circumference, and body fat, were analyzed.
Is interval training the magic bullet for fat loss? A systematic review and meta-analysis comparing moderate-intensity continuous training with high-intensity interval training (HIIT). [2022]To compare the effects of interval training and moderate-intensity continuous training (MOD) on body adiposity in humans, and to perform subgroup analyses that consider the type and duration of interval training in different groups.