Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
Brief Summary: The study investigated the effectiveness of home-based exercise combined with a slight caloric restriction on weight change during 12 months in non-obese women. In addition the investigators evaluate the effects of baseline insulin resistance on modulation of weight change.

A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned to one of two groups: control (CG) and home-based exercise (HB). The HB group received a booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session), in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at a slight energy restriction of 100-300 calories per day.

The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04), but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12 of 18.3 mg/dl in the HB compared to 9.5 in the CG (p\<0.01). At baseline the non-IR group (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected. When the group non-IR and IR were further stratified by GI diet, there were no differences according to diet in both groups. Women classified as IR at baseline had greater weight loss after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences between IR and NIR groups for lipid profile after adjustment for weight changes. During follow-up, changes were more pronounced among those women in the high GI diet. These differences were statistically significant for weight and BMI and were greater among the IR compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the non-IR this value increased (-0.73 vs. +0.37; p=\<0.001). Also this reduction was greater among high compared to low GI diet (p=0.04).


Options:
A: Inclusion Criteria

* Healthy men and women
* Body mass index (BMI) = 25-30
* Slightly overweight, \< 275 lbs
* Women 25-45, pre-menopause
* Men 25-50
* Not traveling often or planning to move

Exclusions:

* Cardiovascular disease or blood pressure greater than 160/90
* Diabetes
* Major psychiatric disorders
* Eating disorders
* Post obese; previous BMI \> 32
* Weight change of more than ten pounds in the past 90 days
* Over 275 pounds
* Smoking
* Regular exercise, more than twice per week
* Current prescription drug use, except oral contraceptives
* Alcoholism or substance abuse
* Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception
* Abnormal electrocardiogram (EKG)
* Local resident for less than one year
* Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.)
* Injuries by any metallic object that is still present in the body
* Braces, non-removable dentures, or non-removable bridgework
B: Inclusion Criteria:

1. Healthy males and female subjects
2. Between the ages of 18 to 45
3. BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight)
4. Willingness to refrain from alcohol during the study
5. Able to come to the FHCRC in Seattle every weekday night for dinner

Exclusion Criteria:

1. Younger than 18 years of age or older than 45 years of age.
2. Do not fit into one of the study weight groups (normal weight and overweight): BMI \< 18.5 kg/m2 or \> 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2
3. Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease
4. Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones)
5. Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible)
6. Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months.
7. Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco).
8. Using recreational drugs
9. Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor.
10. Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet.
C: Inclusion Criteria:

* Men or women age 30-65,
* BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
* At least one of the following components of the metabolic syndrome; fasting triglycerides \> 1,7, fasting glucose 6,0-6,9, HDL-cholesterol \<1,03 (males) or \<1,29 (females), Blood pressure \>130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
* Stable weight range of 4 kg or less the last 12 weeks,
* No major change in physical activity the last 12 weeks

Exclusion Criteria:

* Any symptomatic cardiovascular disease
* Diabetes requiring drug treatment
* Currently on special diet
* Hepatic/renal dysfunction
* Hypothyroidism (unstable)
* GI disorder impairing compliance with diet recommendation,
* History of unstable psychiatric or medical disorder,
* Need of lipid lowering drug,
* Alcohol or drug abuse,
* Participation in drug trial the last 30 days,
* Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
* Obesity of known endocrine origin, history of obesity surgery,
* Uncontrolled hypertension (\>160/100),
* Previous participation in \>3 weight reduction programs, or within last 12 months,
* Not willing to be randomized,
* Individual judged to be unable to follow instructions and procedures of the study
D: Inclusion Criteria:

Non-obese women aged 25-45 years

Exclusion Criteria:

Physician-diagnosed thyroid disease or diabetes or who were menopausal or any other disease that could be influenced by intervention

Answer: D