July 15, 2015/Pediatrics/Research

‘Be Well Kids Clinic’ Provides a Platform for Research into Childhood Obesity

New studies on comorbidities and a novel diet approach for adolescents


By Naim Alkhouri, MD, and Sara Lappé, MD, MS


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In the wake of epidemic levels of childhood obesity in the U.S., Cleveland Clinic Children’s established its Be Well Kids Clinic in April 2013 to provide long-term management of overweight and obese children. At this comprehensive, multidisciplinary clinic, children undergo an extensive baseline evaluation to determine obesity-related medical problems and then participate in a weight management program that involves dietary and behavioral modifications, exercise and, when indicated, medications.

A dual clinical/research mission

In addition to this core clinical mission, the Be Well Kids Clinic is facilitating enhanced research into childhood obesity by Cleveland Clinic Children’s researchers. We profile here two of the research studies that have emerged from the clinic so far:

  • An examination of the comorbidity profile of initial clinic enrollees
  • Experience from one of the earliest reported uses of a protein-sparing modified fast diet in an adolescent population in the outpatient setting

Study 1: Obesity-related comorbidities are widespread, often underdiagnosed

Obese children are at elevated risk of having obesity-related comorbidities such as hypertension, dyslipidemia, diabetes, nonalcoholic fatty liver disease (NAFLD), asthma, obstructive sleep apnea, insulin resistance and others.

To determine the prevalence of such comorbidities in the Be Well Kids Clinic population, we conducted a cross-sectional study involving all children (N = 290) seen at the clinic from its April 2013 opening to May 2014. Data collected included anthropometric measures, family and medical history, examination findings and laboratory results.

The population’s demographic profile was as follows:

  • Mean age, 11.4 ± 7.4 years
  • Mean BMI, 98th percentile (range, 87.2-99.9)
  • 60 percent female
  • 55 percent Caucasian

We found the following prevalences for common comorbidities:

  • Hypertension, 12 percent
  • Prediabetes, 22 percent; diabetes, 2.3 percent
  • Dyslipidemia, 60 percent (either HDL < 40 mg/dL, LDL > 110 mg/dL, triglycerides > 150 mg/dL or total cholesterol > 200 mg/dL)
  • NAFLD, 54 percent among patients undergoing abdominal ultrasound
  • History of obstructive sleep apnea, 13 percent
  • History of asthma, 23 percent

Among children older than 10, 25 percent met International Diabetes Federation criteria for metabolic syndrome. Additionally, 43 percent of patients had elevated ultrasensitive C-reactive protein (> 3 mg/L), indicating chronic inflammation and potentially increased cardiovascular risk. Females had a significantly higher prevalence of insulin resistance (50 percent vs. 33 percent in males; P = .014).


Analysis of the total number of known comorbidities mentioned above revealed that three-quarters of patients had at least one comorbidity and nearly half had two or more (Table).


Our patients had higher rates of dyslipidemia and prediabetes/diabetes compared with nationally representative data. This may be due to the fact that 55 percent of our patients were severely obese and would thus be expected to have a higher prevalence of comorbidities.

Notably, many of these comorbidities were not diagnosed until patients were evaluated in the Be Well Kids Clinic, which suggests that in addition to being exceedingly common, comorbidities in obese children may often be underdiagnosed by pediatricians.

Study 2: Pioneering use of the PSMF diet in obese adolescents

The protein-sparing modified fast (PSMF) diet is a rigorous way of rapidly losing a large amount of body weight. It involves eliminating all carbohydrates and added fats while obtaining nutrition from lean meat, poultry and seafood (hence “modified fast”). The PSMF diet requires close monitoring and a multidisciplinary approach. Data on the use of this diet in adolescents are limited, and some centers require hospital admission for the diet.

Candidates for the diet are severely obese adolescents who have reached skeletal maturity. A dietary assessment is taken at the initial visit to provide patients with a strict dietary regimen and instructions, including a food plan outlining daily nutrient intake. Patients are monitored with frequent laboratory testing to avoid electrolyte imbalances.

Patients attend medical visits biweekly during the first month and then on a monthly basis until weight loss goals are achieved. Typically, the PSMF diet is used for three to six months and then followed by a refeeding phase.


At the Be Well Kids Clinic, we placed 12 adolescents (mean age, 16 ± 2.8 years) with severe obesity on the PSMF diet and followed them for six months. At the three-month follow-up visit, mean weight loss was 9.5 kg (range, 4.1-15.5), and there was a remarkable decrease in mean BMI by six months, from 39.2 to 35.1 kg/m2 (Figure).


Figure. Graph showing changes in BMI among severely obese adolescents (N = 12) on the protein-sparing modified fast (PSMF) diet.

Improvements were also noted in total and HDL cholesterol levels. Side effects reported were nausea (n = 2), decreased energy (n = 1) and transient labile mood (n = 1). Mild weight gain was noted during the refeeding phase over six to eight weeks as patients returned to a more balanced diet with guidance from our medical team.

Counseling continues after diet completion

After patients complete the PSMF diet, we continue to see them in the Be Well Kids Clinic to work on maintaining a healthy diet and weight. Cleveland Clinic Children’s is one of the few tertiary care centers that offer the PSMF diet for rapid weight loss in severely obese adolescents. We plan to continue to study use of the diet in this population to gain further knowledge on its safety and to compare long-term patient outcomes with this severely restrictive diet relative to outcomes following other specialized diets and bariatric surgery.

Dr. Alkhouri is a staff physician in the Department of Pediatric Gastroenterology and Co-Director of the Be Well Kids Clinic.

Dr. Lappé is a staff physician in the Department of General Pediatrics and Co-Director of the Be Well Kids Clinic.

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