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A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity (OH_APADIET)

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ClinicalTrials.gov Identifier: NCT03673813
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

Condition or disease
Hypothalamic Obesity

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Individual Nutritional Support at Home for Patients With Hypothalamic Obesity: Efficacy on Eating Behavior, Physical Activity, Physical Abilities, Weight Gain and Quality of Life
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018





Primary Outcome Measures :
  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. [ Time Frame: month 4 ]
    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.


Secondary Outcome Measures :
  1. Measurement of weight in kg before and after the 4 months program [ Time Frame: month 4 ]
    In day hospital before and 4 months after supervised program (weight measured during the evaluations) and monthly measurement at home of the patient during 4 months (reported by the patient and his entourage and recorded by the dietician during the monthly telephone interview).

  2. Evolution of the parameters evaluating the feeding behavior [ Time Frame: month 4 ]
    Score of Dyckens questionnaire ( 3 subscores behavior, drive and severity) before and after the 4 months program

  3. Evolution the physical function before and after the 4 months program [ Time Frame: month 4 ]
    A 6-min walk test distance (meters)

  4. Evolution of body composition (fat mass in kg and % evaluated by DEXA) [ Time Frame: month 4 ]
    lean mass and fat mass in kg and in% (DEXA)

  5. Evolution of the quality of life [ Time Frame: month 4 ]
    self-questionnaire of the patient (SF12)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with hypothalamic obesity (lesional or genetic)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Introduction of new treatments in the 2 months preceding inclusion that can modify the feeding behavior (GLP1 analogues, Topiramate, psychotropic drugs, etc.).
  • Decompensation of a cardiorespiratory or psychiatric pathology in the 3 months preceding the inclusion.
  • 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.).
  • Subject in exclusion period after participation in another clinical trial.
  • Pregnancy, breastfeeding.
  • Interruption of more than 15 days of the foreseeable monitoring protocol (leave etc ..).

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03673813     History of Changes
Other Study ID Numbers: HAO17-Poitou_20170220
2016-A00385-46 ( Registry Identifier: RCB )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypothalamic obesity
Prader-willi syndrome
Physical activity

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms