- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02290184
PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Filipino Americans are the second largest Asian population and fastest growing racial group in the United States. They have one of the highest rates of insulin resistance (type 2 diabetes = T2DM) and central obesity (fat distributions primarily in the abdominal region). T2DM and central obesity are two of five major risk factors for metabolic syndrome that lead to cardiovascular disease and stroke. Key factors contributing to obesity and T2DM in Filipinos are their physical inactivity, and a diet high in fat and soda intake. However, there are very few research studies on improving health behaviors to reduce risks for metabolic syndrome in Filipino Americans. To help reduce the risk of developing metabolic syndrome in overweight/obese Filipino Americans with T2DM, the proposed project will test a culturally appropriate health behavior intervention program to reduce weight and waist circumference, through increasing physical activity, and lowering fat and sugar sweetened beverage intake. This intervention uses a mobile phone health app and social networking to encourage adherence to target health behaviors. The goals are to:
- To assess feasibility and acceptability of the culturally appropriate PilAm Go4Health Weight Loss Program
- To obtain preliminary estimates of the effect of the intervention on weight
- To conduct post-program process evaluations too improve the intervention relevancy for the target population.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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California
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San Francisco, California, Förenta staterna, 94115
- San Francisco / Daly City Communities
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Self-identified as Filipino
- Age > 18 years
- BMI for Asians > 23 kg/m2
- Physician diagnosed T2DM diabetes confirmed by clinical data (e.g. documentation of fasting blood glucose >126 mg/dL or a positive oral glucose tolerance test (OGTT) > 200 mg/dl, HbA1c > 6.5%)
- On metformin for T2DM
4) waist circumference: men > 40 inches, women > 35 inches 6) Physically inactive - most leisure time spent without much physical activity 7) No cognitive impairment per the Mini-Cog test 8) has a mobile smart phone (iPhone 4s or above, or android phone) 9) English speaking. Only one member per household allowed to enroll in the study.
Exclusion Criteria:
- Uncontrolled T2DM
- Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
- Known medical conditions or other physical problems needing a special exercise program (e.g., prior myocardial infarction, history of angioplasty or angina, admission for hospital evaluation of chest pain, use of nitroglycerin for angina, chronic obstructive pulmonary disease, or uncontrolled hypertension)
- Recent acute coronary syndrome, congestive heart failure
- Currently participating in a lifestyle modification program
- Planning a trip outside of the US during the 6-month study period
- Known eating disorder
- Planning a surgery in the next 7-months
- Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Intervention - PilAm Go4Health Program
In the first 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention.
After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.
|
This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin.
Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).
Andra namn:
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Aktiv komparator: Active control - pedometer only
In the first 3 months this groups will start with a pedometer only.
After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months
|
This is a 3-month active control using a pedometer only without any education related to wt loss, physical activity, health eating, or tracking healthy behaviors
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility for Participant Enrollment and Retention
Tidsram: Baseline to 6-months
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Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
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Baseline to 6-months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight Change in Kilograms
Tidsram: Baseline to 3 months
|
weight change in kilograms over a 3 month period.
Intervention group will have a significantly greater reduction in weight change compared to the active control from baseline to 3-months
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Baseline to 3 months
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Percent Change in Weight (kg) From Baseline and 3 Months
Tidsram: Baseline to 3 months
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100 x change in weight (kg) at 3 months divided by weight (kg) at baseline.
Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months.
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Baseline to 3 months
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Change in Waist Circumference
Tidsram: baseline to 3 months
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Change in waist circumference over time within groups
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baseline to 3 months
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Melinda S Bender, PhD, University of California, San Francisco
Publikationer och användbara länkar
Allmänna publikationer
- Bender MS, Cooper BA, Park LG, Padash S, Arai S. A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial. JMIR Diabetes. 2017 Dec 12;2(2):e30. doi: 10.2196/diabetes.8156. Erratum In: JMIR Diabetes. 2018 Dec 21;3(4):e12784.
- Bender MS, Santos GM, Villanueva C, Arai S. Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial. JMIR Res Protoc. 2016 Sep 8;5(3):e178. doi: 10.2196/resprot.5836.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-14158
- 14CRP19560008 (Annat bidrag/finansieringsnummer: American Heart Association)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003. That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses.
Requests will be reviewed and acted on by the PI or in consultation with a UCSF representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a CD or through a password-protected download from our website.
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- CSR
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på PilAm Go4Health Weight-loss Program
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Yale UniversityAvslutadViktminskning | Övervikt och fetma | MatberoendeFörenta staterna
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University of California, San DiegoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) och andra samarbetspartnersAvslutadÖvervikt och fetmaFörenta staterna
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Walter Reed Army Medical CenterAvslutadDiabetes mellitus typ 2
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University of ConnecticutNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) och andra samarbetspartnersRekrytering
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University of VermontAvslutad
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The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalAvslutad
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Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)AvslutadFetmaFörenta staterna
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Aktiv, inte rekryterandeFetma | Övervikt | Övervikt och fetmaFörenta staterna
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Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, inte rekryterandeFetma | HetsätningsstörningFörenta staterna