Exercise Modes for Obesity

Phase-Based Estimates
1
Effectiveness
1
Safety
East Carolina University, Greenville, NC
+4 More
Exercise Modes - Behavioral
Eligibility
18 - 65
Female
Eligible conditions
Obesity

Study Summary

Pregnancy Exercise Mode Effect on Childhood Obesity

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Eligible Conditions

  • Obesity
  • Pediatric Obesity
  • Overweight
  • Overweight and Obesity
  • Pregnant State

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Exercise Modes will improve 11 primary outcomes and 62 secondary outcomes in patients with Obesity. Measurement will happen over the course of 16 weeks gestation.

1 month
1 month Infant BMI z-score
1 month Infant Blood Biomarkers (CRP)
1 month Infant Blood Biomarkers (IL6)
1 month Infant Blood Biomarkers (adiponectin)
1 month Infant Body Fat %
1 month Infant Metabolomics
1 month Infant Resting Blood Pressure
1 month Infant Resting Heart Rate
1 month Infant Veggie Meter
1 month Infant non-HDL
1 month postpartum
1 month Postpartum Maternal Biomarkers (IL6)
1 month Postpartum Maternal Biomarkers (adiponectin)
1 month Postpartum Maternal Biomarkers (cortisol)
1 month Postpartum Maternal Body Fat%
1 month postpartum Maternal Biomarkers (CRP)
1 month postpartum Maternal Resting Blood Pressure
1 month postpartum Maternal Resting Heart Rate
1 month postpartum Maternal fasting non-HDL
1 months
1 month Infant % Muscle Mass
1 month Infant Neuromotor Assessment
1 month Infant Resting Energy Expenditure (REE)
12 months
12 month Infant % Muscle Mass
12 month Infant BMI z-score
12 month Infant Blood Biomarkers (CRP)
12 month Infant Blood Biomarkers (IL6)
12 month Infant Blood Biomarkers (adiponectin)
12 month Infant Body Fat %
12 month Infant Neuromotor Assessment
12 month Infant Resting Blood Pressure
12 month Infant Resting Energy Expenditure (REE)
12 month Infant Resting Heart Rate
12 month Infant Veggie Meter
12 month Infant non-HDL
12 months Infant Metabolomics
16 gestation
16wk Maternal Resting Heart Rate
16 weeks gestation
16wk Maternal Biomarkers (CRP)
16wk Maternal Biomarkers (IL6)
16wk Maternal Biomarkers (adiponectin)
16wk Maternal Biomarkers (cortisol)
16wk Maternal Body Fat%
16wk Maternal Resting Blood Pressure
36 weeks gestation
36wk Maternal Biomarkers (CRP)
36wk Maternal Biomarkers (IL6)
36wk Maternal Biomarkers (adiponectin)
36wk Maternal Biomarkers (cortisol)
36wk Maternal Body Fat%
36wk Maternal Resting Blood Pressure
36wk Maternal Resting Heart Rate
36wk Maternal fasting non-HDL
6 month
6 month Infant Blood Biomarkers (adiponectin)
6 months
6 month Infant % Muscle Mass
6 month Infant BMI z-score
6 month Infant Blood Biomarkers (CRP)
6 month Infant Blood Biomarkers (IL6)
6 month Infant Body Fat %
6 month Infant Metabolomics
6 month Infant Neuromotor Assessment
6 month Infant Resting Blood Pressure
6 month Infant Resting Energy Expenditure (REE)
6 month Infant Resting Heart Rate
6 month Infant Veggie Meter
6 month Infant non-HDL
6 months postpartum
6 month Postpartum Maternal Biomarkers (CRP)
6 month Postpartum Maternal Biomarkers (IL6)
6 month Postpartum Maternal Biomarkers (adiponectin)
6 month Postpartum Maternal Biomarkers (cortisol)
6 month Postpartum Maternal Body Fat%
6 month postpartum Maternal Resting Blood Pressure
6 month postpartum Maternal Resting Heart Rate
6 months postpartum Maternal fasting non-HDL
At Delivery
Adverse Pregnancy Outcomes
at delivery
Maternal Gestational Weight Gain (GWG)
enrollment (~8-13 wks gestation)
Enrollment (8-13wks) Maternal fasting non-HDL

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Resistance Exercise (RE)

This trial requires 300 total participants across 3 different treatment groups

This trial involves 3 different treatments. Exercise Modes is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Resistance Exercise (RE)
Behavioral
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.[100] Seated isokinetic exercise using Cybex machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends).
Combination Exercise (AERE)
Behavioral
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AERE group will switch between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeated repeat with different exercises.[106-108] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups.
Aerobic Exercise (AE)
Behavioral
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
L. M.
Prof. Linda May, Associate Professor; Interim Dept. Chair
East Carolina University

Closest Location

East Carolina University - Greenville, NC

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A singleton pregnancy is a pregnancy with one fetus show original
during pregnancy It is safe for pregnant women to exercise as long as they have clearance from their obstetrician show original
We are looking for someone who is 18 to 40 years old. show original
BMI between ≥ 25

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get obesity a year in the United States?

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Obesity affects 30.2% of the US female population and 24.9% of the male population with the most obese being Hispanic, black African American, and Asian/Pacific Islander. On average there are over 2.6 million individuals in the US overweight or obese with 13% of the population being obese.\n

Unverified Answer

Can obesity be cured?

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Although obesity does not have an impact on morbidity or all-cause mortality, it has been associated with adverse cardiovascular risk profiles, as measured by serum lipid concentrations and some aspects of arterial function. In addition, obesity has been associated with insulin resistance, which has been related to the development of type 2 diabetes. This suggests that obesity can be managed with a goal of reducing the risk of type 2 diabetes and related risk profiles.

Unverified Answer

What are the signs of obesity?

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Signs of obesity include excessive eating, lack of exercising, and lack of physical activity. Overweight people often eat larger amounts of food than their lean counterparts. Obese individuals also tend to have a larger body-mass index. Being overweight has been tied to psychological and social problems in the recent past. Overweight people often experience weight-related problems which persist and increase with the onset of puberty. Obesity is associated with many chronic illnesses such as high blood pressure, diabetes, high cholesterol, heart disease, and sleep issues.

Unverified Answer

What are common treatments for obesity?

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Results from a recent clinical trial identified the following characteristics of common treatments for obesity, which can be used in informing patients prior to making treatment decisions: (1) the benefits outweigh the risks and side effects, and (2) an initial treatment plan that includes a series of short, gradual weight loss events (i.e., diet and exercise) usually results in complete remission of the symptoms within 1 to 2 years.

Unverified Answer

What causes obesity?

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Obesogenesis can be conceptualised as a consequence of complex interactions in which the genetic make-up determines an individual's metabolic state, a high-fat diet is chosen despite the fact that the individual has a high genetic susceptibility to acquiring metabolic disease, and an environmental risk factor for metabolic disease precipitates the diet choices. Such a conceptualisation may be useful in developing an understanding of obesity. Although this explanation may be simplistic, it may also be helpful in identifying the many interactions that occur between genes, diet and environment in the development of obesity.

Unverified Answer

What is obesity?

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Obesity is defined as a BMI that is greater than or equal to 30 kg/m(2). An average of about 7.2 million American men and women now are classified as morbidly obese. To summarize, this article will describe obesity in an attempt to raise awareness about the potential health consequences of obesity. An important clue of the health-related problems of obesity is that most of the cases of obesity (about 90-95%) are the result of a combination of genetic and environmental factors. Obesity is a major public health problem that has become worse in last few decades and is an urgent challenge for our country and world.

Unverified Answer

What are the latest developments in exercise modes for therapeutic use?

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Exercise modes with an emphasis on low impact exercises, such as yoga, tai chi, Pilates, and gymnastics, can be helpful to patients who are recovering from injury or illness. Yoga, tai chi, and Pilates have proven to be effective when compared to a control treatment group. Yoga and tai chi have the most extensive evidences.

Unverified Answer

Is exercise modes safe for people?

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There is evidence to suggest that long-term HIIT exercise provides an important contribution to exercise-induced heart rate reduction, even in highly sedentary and obese individuals. Long term HIIT exercise appears to be a safe exercise mode for people of all fitness levels. However, HIIT training has not been well studied for people under 40 years of age, and long term cardiorespiratory rehabilitation needs further rigorous evaluation to establish its safety and efficacy in this age group.

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What is the average age someone gets obesity?

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About 5% of a population becomes obese at age 45 years, the oldest age reported, but the average age that obesity begins is around the age of 4.7 years. Obesity is rare until the age of 50 years and by that age up to 2% of a population is obese. In the United Kingdom obesity starts to climb at age 10: about one in four children start to become obese by the time they are 14. There is a sex difference in average body mass: in the United Kingdom males are 8% or 1.1 oz (less than 1 stone) heavier than females.

Unverified Answer

What is exercise modes?

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Exercise is a part of exercise theory that emphasizes that in order to perform a physical activity, the individual must be in a balanced state that will contribute a favorable level of effort while being able to maintain a sufficiently high degree of skill to avoid being inefficient in the use of energy. The different exercise modes are the result of the person's level of fitness, the intensity of activity, and what is to be done. In general, aerobic exercise is generally considered beneficial in the case of overweight people. Although many people do their aerobic exercise at a low intensity, a majority of the research shows that aerobic exercise is beneficial even in case of obesity.

Unverified Answer

Have there been any new discoveries for treating obesity?

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More research on a large scale must be made, and the existing studies still need to be expanded because many don't really take into consideration that obesity as a disease is complex and must be treated individually for all people who are affected by the same problems and causes. Although there aren’t a lot of drugs currently being used for obesity most of the drugs are the same drugs that are prescribed for type 2 diabetes(which is basically insulin.) For a person if is treated like type 2 diabetes then that person will have to take insulin, but if you have type 2 and you already take insulin the doctor will say “you don’t need the insulin too much.

Unverified Answer

Is exercise modes typically used in combination with any other treatments?

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Despite the positive results reported by some authors, there is a paucity of data demonstrating that different modes of exercise in combination with any type of treatment effectively prevent or treat common diseases, such as obesity, diabetes mellitus, high blood pressure, hyperlipidemia.

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