Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (MAMAO2)

12 lipca 2018 zaktualizowane przez: VA Office of Research and Development

Management of Antipsychotic Medication Associated Obesity - 2

This program aims to help Veterans who take antipsychotic medications lose weight. We use a program based on the American Diabetes Association's "Diabetes Prevention Program," and we have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

121

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Long Beach, California, Stany Zjednoczone, 90822
        • VA Long Beach Healthcare System, Long Beach, CA
      • Sepulveda, California, Stany Zjednoczone, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
      • West Los Angeles, California, Stany Zjednoczone, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Must be a Veteran
  • Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
  • Age 18-70
  • Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
  • Experienced weight gain since treatment with SGA's
  • Inpatient or outpatient at Long Beach, West Los Angeles, Sepulveda, or Downtown VA
  • Competent to sign informed consent

Exclusion Criteria:

  • Have recently been diagnosed with schizophrenia (less than 1 year)
  • Are pregnant or breast feeding a baby
  • Have a medically unstable condition

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Usual Care
Control group with time-matched study visits
Aktywny komparator: Lifestyle Balance
Weight management group education and individual counseling
Behawioralne: Lifestyle Balance
Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition
Inne nazwy:
  • Lifestyle Balance Program
Inny: Usual Care then Lifestyle Balance
Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.
Behawioralne: Lifestyle Balance
Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition
Inne nazwy:
  • Lifestyle Balance Program

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Weight Change Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Waist Circumference Change Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Serum Insulin Level Change Per Week From Baseline to Termination
Ramy czasowe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean Triglycerides Level Change Per Week From Baseline to Termination
Ramy czasowe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Ramy czasowe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Ramy czasowe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.
Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Change in Mean Total Calories Consumed Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Change in Mean Total Exercise Time Per Week From Baseline to Termination
Ramy czasowe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Ramy czasowe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.
Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

VA Office of Research and Development

Śledczy

  • Główny śledczy: Donna Ames, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2010

Zakończenie podstawowe (Rzeczywisty)

28 maja 2015

Ukończenie studiów (Rzeczywisty)

28 maja 2015

Daty rejestracji na studia

Pierwszy przesłany

15 stycznia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 stycznia 2010

Pierwszy wysłany (Oszacować)

20 stycznia 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 sierpnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2018

Ostatnia weryfikacja

1 lipca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D7358-R

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Lifestyle Balance

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Switzerland

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj