Homeopathy for Overweight and Obesity in Mexican Adolescents

Study Overview
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Brief Summary
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This study evaluates the efficacy of a multidisciplinary intervention (diet, exercise, motivational support and homeopathy or placebo) for overweight and obesity in Mexican adolescents. Half of study participants will receive the multidisciplinary intervention plus Calcarea carbonica ostrearum, a homeopathic medicine, while the other half will receive the same multidisciplinary intervention plus placebo.

Detailed Description
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Overweight and obesity in children and adolescents are a major public health issue in Mexico. Whilst many factors (genetic, cultural, socioeconomic and environmental) contribute to develop obesity during childhood, a multidisciplinary intervention (nutritional, behavioral and exercise) is the best approach to improve weight loss. In Mexico, the use of homeopathy for obesity is widespread. Although there are some homeopathic medicines used for obese individuals, there is a lack of well-designed clinical trials to demonstrate its efficacy in weight loss. Calcarea carbonica ostrearum is a homeopathic mineral medicine. Previously, it has been demonstrated that Calcarea carbonica has an effect in reducing the percentage of fat in adolescents. Therefore, a randomized, placebo-controlled, double-blind, parallel, superiority trial with a 3 month study duration, will be conducted to prove the efficacy and safety of Calcarea carbonica ostrearum in reducing weight, body mass index (BMI) and fat percentage, as well as, to prove its effect on the lipid profile, fasting serum glucose, glycosylated hemoglobin and insulin.

Official Title
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Efficacy of a Multidisciplinary Intervention and Homeopahy for Overweight or Obesity in Mexican Adolescents: a Study Protocol for a Randomized Double-blind, Placebo-controlled Trial

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Drug: Homeopathic Medication
* Other: Multidisciplinary intervention (Exercise program, diet, motivational support)
* Drug: Homeopathic placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 to 19 years old. At least elementary school. Overweight (BMI ≥ 85th but <95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile). Fasting serum glucose <126 mg/dl. Glycosylated hemoglobin <6.5%. With symptoms that match with Calcarea carbonica ostrearum. Willingness to participate, and verbal and written consent. Exclusion Criteria: Pregnancy or breastfeeding. Cases already undergoing treatment (homeopathic, nutritional or structured physical activity) for obesity within last three months. Currently use of metformin, orlistat, insulin, other antidiabetic medication, contraceptive pills, medications with effects on lipid metabolism [thiazide and loop diuretics, β and α receptor blockers, antiepileptic drugs (carbamazepine, phenytoin, valproic acid, phenobarbital), antipsychotics (clozapine), protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), tamoxifen, raloxifene, isotretinoin, acitretin, ciclosporin, azathioprine, sirolimus]. Any condition that prevents physical exercise. Diabetes, hypertension, thyroid diseases, Down syndrome, mental retardation.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, placebo-controlled, double-blind, parallel, superiority trial with 3 month study duration.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary intervention + homeopathic medication<br>Multidisciplinary intervention (diet, exercise program, motivational support) and Calcarea carbonica ostrearum 30c. A single dose of Calcarea carbonica ostrearum 30C dissolved in a 30 ml bottle of 30% alcohol-distilled water. Patients will receive 8 drops PO three times per day prior agitation. | Drug: Homeopathic Medication<br>* A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.<br>* Other names: Calcarea carbonica ostrearum;Other: Multidisciplinary intervention (Exercise program, diet, motivational support)<br>* Exercise program: includes a five-times per week routine: warm-up during 10 to 15 minutes, then 40 minutes of aerobic exercise that will be increased progressively until reaching 60 minutes. Thereafter, muscular strength initiating 5%, and increasing until 10 to 15% of body weight. Then, 10 to 15 minutes of stretching. Finally, 5 min cool-down. Diet: Subjects will receive a balance diet calculated based on energetic needs according FAO: 15-20% of proteins, 50-60% of carbohydrate, 20-25% of fat per day. Motivational support: 50 min session where empathy and neutral understanding of the perspective and feelings of the adolescent, and his family, are fostered to motivate the change and to state realistic goals in reducing weight.<br>* Other names: Combined dietary-behavioral-physical activity intervention;|
| Active Comparator: Multidisciplinary intervention + homeopathic placebo<br>Multidisciplinary intervention (diet, exercise program, motivational support) and placebo. Placebo will be prepared with 30% alcohol-distilled water only, in the same 30 ml bottle. Patients will receive 8 drops PO three times per day prior agitation. | Other: Multidisciplinary intervention (Exercise program, diet, motivational support)<br>* Exercise program: includes a five-times per week routine: warm-up during 10 to 15 minutes, then 40 minutes of aerobic exercise that will be increased progressively until reaching 60 minutes. Thereafter, muscular strength initiating 5%, and increasing until 10 to 15% of body weight. Then, 10 to 15 minutes of stretching. Finally, 5 min cool-down. Diet: Subjects will receive a balance diet calculated based on energetic needs according FAO: 15-20% of proteins, 50-60% of carbohydrate, 20-25% of fat per day. Motivational support: 50 min session where empathy and neutral understanding of the perspective and feelings of the adolescent, and his family, are fostered to motivate the change and to state realistic goals in reducing weight.<br>* Other names: Combined dietary-behavioral-physical activity intervention;Drug: Homeopathic placebo<br>* A 30 ml bottle of 30% alcohol-distilled water.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean total weight in kilograms (kg) | Weight measured with the participants barefooted and lightly dressed, with a Tanita scale Fitscan BC-545 F segmental body composition monitor. The scale has an eight electrode body composition monitor that displays twenty readings; ten whole body and ten segmental (arms, legs and trunk area). | At baseline and week 4, 8 and 12. | 
| Change from baseline in percentage of body fat | Body fat measured with Tanita scale Fitscan BC-545 F segmental body composition monitor. Values greater than 30% for females, and 25% for males, are considered high and of risk | At baseline and week 4, 8 and 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean total body mass index (BMI). | Weight/height2 (kg/m2). Overweight (BMI ≥ 85th but <95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile). | At baseline and week 4, 8 and 12. | 
| Change from baseline in mean total fat mass index | Calculated by dividing fat weight in kilograms by height in meters squared. | At baseline and week 4, 8 and 12. | 
| Change from baseline in mean total lean body mass (kg). | Calculated by subtracting body fat weight from total body weight: total body weight is lean plus fat | At baseline and week 4, 8 and 12. | 
| Change from baseline waist-hip ratio. | Calculated as waist measurement divided by hip measurement. | At baseline and week 4, 8 and 12. | 
| Change from baseline in mean total lean muscle mass (kg). | Calculated by total weight of the body minus all the weight due to the fat mass. | At baseline and week 4, 8 and 12. | 
| Number and severity of all adverse events | Adverse event will be defined as any untoward medical occurrence in a subject without regard to the possibility of a causal relationship. | After participants consent and enrolled in the study and 15 days after study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Homeopathy, Calcarea carbonica ostrearum, Mexico