A Mobile Based Diabetes Prevention Program
mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
The goals of the study are to:
- Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group.
- To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.
- To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.
Přehled studie
Postavení
Detailní popis
The prevalence of type 2 diabetes (T2DM) continues to rise at an alarming rate in the United States. A greater risk of diabetes is observed for ethnic/racial minority and lower socioeconomic status (SES)groups as compared to Caucasians of similar ages. Several clinical trials have tested intensive lifestyle interventions or pharmacologic agents in preventing or delaying T2DM in adults at risk. These trials (e.g.the Diabetes Prevention Program) consistently show impressive diabetes risk reductions using lifestyle interventions, such as relatively modest amounts of weight loss and exercise. However these programs have been expensive to implement and sustain over time in clinical settings or communities.
Mobile technologies are ideal platforms to deliver and disseminate such lifestyle modification programs to a much broader ethnic/racial minority population, making them more cost effective. Today, 87% of adults in the U.S. own a mobile phone. In particular, usage of non-voice services (such as text messaging or mobile internet) in African-Americans and non-white Hispanics is significantly higher than their Caucasian counterparts. In contrast, ethnic /racial minority populations are much less likely to own a computer at home compared to their Caucasian counterparts. Given the rapid diffusion of mobile technologies in ethnic/racial minority populations, we need to understand how to apply mobile persuasive technologies to such lifestyle modification programs.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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San Francisco, California, Spojené státy, 94118
- University of California San Francisco
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Sedentary lifestyle at work and/or during leisure time
- Intend to be physically active
- Are over 25 years of age
- Access to a home telephone or a mobile phone
- Speak and read English
- Are not physically active
- Have no disabilities that limit physical activity
- Have high blood sugar (fasting blood sugar 100-125) but do not have diabetes
Exclusion Criteria:
- Known medical conditions or other physical problems that need special attention in an exercise program
- Plan a trip abroad during the first 5 months of the study period.
- Pregnant/Delivered a baby during the last 6 months
- Known severe hearing or speech problem
- Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study
- History of gastric bypass surgery or future plans for gastric bypass surgery in the next 5 months
- Already taking medication for diabetes
- Recovery from addiction
- Known eating disorders
- Bmi over 25 if non-Asian or over 23 if Asian
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Physical Activity and Diet Intervention
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
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This group will receive a mobile phone software program and a pedometer.
Over a 5-month period, participants in this group will be asked to participate in 6 in-person sessions, wear a pedometer, use a mobile phone physical activity and diet diary, and respond to daily physical activity and diet messages or video clips.
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Aktivní komparátor: Pedometer only
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This group will receive a pedometer.
Over a 5-month period, participants in this group will be asked to wear a pedometer.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Body weight (kg)
Časové okno: 5 months
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5 months
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Body mass index
Časové okno: 5 months
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5 months
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Časové okno: 5 months
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5 months
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Total daily calories (kcal)
Časové okno: 5 months
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5 months
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Daily calories from fat (kcal)
Časové okno: 5 months
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5 months
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Fasting plasma glucose
Časové okno: 5 months
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5 months
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Yoshimi Fukuoka, Ph.D., University of California, San Francisco
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1107481
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