A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity

NCT03673813 | Completed

• 2 other identifiers: HAO17-Poitou_201702202016-A00385-46
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothalamic obesity (HO) is an obesity secondary to an alteration of the functioning of the hypothalamus, the central organ of energy homeostasis. The causes of OH are related to an hypothalamic lesion (eg craniopharyngioma) or to genetic diseases (ex: Prader-Willi syndrome). OH, which accounts for about 5 to 10% of obesity, is a complex handicap characterized by severe obesity associated with eating disorders, cognitive and behavioral disorders and sometimes a visual deficit, with a major impact on quality of life, morbidity and mortality. There is currently no specific treatment of HO. Management is essentially behavioral, based on daily support of eating behavior and physical activities (PA). OH is characterized by an intense and almost permanent hunger felt, a satiety disorder and an obsessive interest in food. The food education of the entourage is essential, the advise concern the control of the access to food and the setting up of a precise food frame on the quantities, with low energetic density, and schedules. OH is characterized by obesity with lean mass deficit. PA must therefore be regular, adapted to the disability and personalized to take into account cognitive deficits and behavioral disorders. Although the supervision of meals and daily PA is now recognized as fundamental in the care of these patients (National Program of Diagnosis and Care established by the French "Haute Autorité de Santé"), few studies have evaluated the effectiveness of programs with personalized support on global health. The investigators hypothesize that a personalized 4-month individual home-based counseling program on dietary counseling and PA can be effective to modify behaviors such as diet and PAs with an impact on changing weight and quality of life. The 16-week program includes a dietetic component (initial assessment with dietary care plan followed by a 30-minute telephone interview every month with dietician) and a PA component (two 1-hour individualized sessions, performed at home and supervised by a PA educator). Before and after the program, the investigators will evaluate habitual PA with an accelerometer, feeding behavior, physical functioning, weight change, body composition, quality of life and will constitute a biobank of serums, adipose tissues and stools. If the effectiveness of this program is demonstrated this will help to find ways to sustain this support by the institutions, to train professionals in the complex accompaniment of these patients. Finally this program set up as part of a rare disease can show the benefits in other populations of more common pathology (common severe obesity, intellectual disability, behavioral disorders).

Conditions

Hypothalamic Obesity

Keywords

Hypothalamic obesity; Prader-willi syndrome; Physical activity

Outcome Measures

Primary Outcomes (1)

• Compare the activity count (counts/mn) and pattern of activity (sedentarity time, light, moderate in %) measured objectively by an accelerometer before and after a 16-week program including a dietetic component and a PA component. Support over 4 months.

  PA volume indicator (taking into account the duration and intensity of the APs used) expressed in counts per minute, measured for 1 week objectively by an accelerometer (Actigraph GT3X®).advice and food intake control and a program of adapted physical activities at home in individual support.

  month 4

Secondary Outcomes (5)

• Measurement of weight in kg before and after the 4 months program

  month 4

• Evolution of the parameters evaluating the feeding behavior

  month 4

• Evolution the physical function before and after the 4 months program

  month 4

• Evolution of body composition (fat mass in kg and % evaluated by DEXA)

  month 4

• Evolution of the quality of life

  month 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with hypothalamic obesity (lesional or genetic)

You may qualify if:

• Male or female subject aged 18 to 60
• BMI ≥ 30kg / m² or MG ≥ 35% of total weight in men / 40% of total weight in women
• "Hypothalamic" obesity, defined as obesity with hyperphagia, and cognitive or neuropsychological disorders
• Entourage present (family or educator)
• Treatments not modified for at least 2 months (growth hormone, gonadotropic / thyrotropic / corticotropic substitution, Minirin, psychotropic drugs, etc.)
• Affiliation to a social security scheme

You may not qualify if:

• Subject in a situation that, in the opinion of the investigator, could interfere with his / her optimal participation in the study (eg severe behavioral disorders) or constitute a particular risk for the patient (eg severe cardiorespiratory pathology).
• Contraindication to the physical activity discovered during the first evaluation (electrocardiogram abnormalities, abnormal stress test, abnormal cardiac echocardiography or effort scintigraphy, etc.).
• Pregnancy, breastfeeding.
• Interruption of more than 15 days of the foreseeable monitoring protocol (leave etc ..).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Sexual Infantilism; Prader-Willi Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: September 17, 2018
• Study Start: June 29, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-07