A Phase 2 interventional study of Homeopathic Medication and Multidisciplinary intervention (Exercise program, diet, motivational support) in Overweight and Obesity, sponsored by Hospital Juarez de Mexico. Status unknown at 1 site in Mexico. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Hospital Juarez de Mexico · Phase 2, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Hospital Juarez de Mexico is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Multidisciplinary intervention (Exercise program, diet, motivational support)
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) · Drug: Homeopathic placebo
A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.
Also known as: Calcarea carbonica ostrearum
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.
Also known as: Combined dietary-behavioral-physical activity intervention
A 30 ml bottle of 30% alcohol-distilled water.
Also known as: Placebo
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).
Time frame: 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
Time frame: At baseline and week 4, 8 and 12.
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).
Time frame: 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.
Time frame: 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
Time frame: At baseline and week 4, 8 and 12.
Change from baseline waist-hip ratio.
Calculated as waist measurement divided by hip measurement.
Time frame: 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.
Time frame: 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.
Time frame: After participants consent and enrolled in the study and 15 days after study completion.
Change from baseline in mean total fasting serum glucose (mg/dL)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200). Glucose will be assayed by the glucose-oxidase method.
Time frame: At baseline and week 12.
Change from baseline in mean total fasting serum triglycerides (mg/dL)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time frame: At baseline and week 12.
Change from baseline in mean total cholesterol (mg/dL)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time frame: At baseline and week 12.
Change from baseline in mean total high-density cholesterol (mg/dL)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time frame: At baseline and week 12.
Change from baseline in mean total low-density cholesterol (mg/dL)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time frame: At baseline and week 12.
Change from baseline in percentage of glycosylated hemoglobin
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using an automated chemical analyzer (Advia®1200).
Time frame: At baseline and week 12.
Change from baseline in mean total insulin (mU/ml)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using a chemiluminescence technique (Immulite®2000TSH Third Generation).
Time frame: At baseline and week 12.
Change from baseline in mean total thyroid-stimulating hormone (mU/L)
Blood samples will be collected by venipuncture in the antecubital region of patients after 10-12 hours of overnight fasting and centrifuged within 30-45 min of collection, using a chemiluminescence technique (Immulite®2000TSH Third Generation).
Time frame: At baseline and week 12.
Change from baseline in mean total HOMA-IR.
The homeostasis model assessment (HOMA), an epidemiologic method for assessing insulin resistance \[HOMA-IR=insulin (mU/ml) X glucose (mg/dl)/405\] will be used as surrogate measure of insulin sensitivity
Time frame: At baseline and week 12.
Change from baseline in mean total score of CES-D-R
CESDR scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. The range of possible scores is between 0 (for those who say 'not at all or less than one day to all 20 questions' and 60 (for those who say '5-7 days' or 'nearly every day for 2 weeks' for all 20 questions). No clinical significance: a total CESD-R score less than 16 across all 20 questions.
Time frame: At baseline and week 12.
Change from baseline in mean total score of Screen for Child Anxiety Related Emotional Disorders (SCARED).
Appropriate screening tool to aid the diagnosis of anxiety disorders in adolescents attending an outpatient clinic.It consists of 41 items that are rated from 0 to 2, being 0 never, 1 sometimes and 2 always. The cut-off point is 25, that is, there is a probability of at least 70% that the child or adolescent has an anxiety disorder.
Time frame: At baseline and week 12.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Juarez de Mexico