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ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet (ENGAGED)

10. listopadu 2016 aktualizováno: Bonnie Spring, Northwestern University
The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals. All participants will receive an effective weight loss treatment: either self-guided or group formats. All treatment will be provided in the Department of Preventive Medicine at Northwestern University. Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies. Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study. All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study. Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins. Participants will be compensated for completing each of the 3 follow-up assessments. All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard weight loss treatment for adults with cardiometabolic risk factors. Despite its efficacy, the DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a specialist are considered too burdensome and expensive to be a sustainable program. Attempts to reduce cost by decreasing session number have yielded greatly diminished weight loss. Behavioral adherence to diet and activity goals declines and weight regain routinely begins once frequent face-to-face meetings cease. The still unmet challenge of DPP implementation is how to reduce treatment intensity without excising the regular social support, accountability, and feedback that are essential to maintain adherence. We hypothesize that it is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as efficiently by using hand held technology to preserve feedback, accountability, and regular social support. The smartphone-based technology system to be tested is guided by Carver and Scheier's control systems theory of self-regulation. Initial formative research will upgrade the smartphone with engaging features that motivate participants to use the device to self-monitor and interact with a coach and peer support group. Use of the finalized tool will be compared to usual recording on paper records in a preliminary 3-group randomized controlled trial (RCT) involving 96 obese adults. By enabling peer support, accountability, and feedback on diet, physical activity, and weight loss goals continuously through the 6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of diet and activity goals], and (2) weight loss. An enabling technology that integrates specialist and peer support resources to improve treatment adherence could help to curtail the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP lifestyle intervention.

Typ studie

Intervenční

Zápis (Aktuální)

96

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Illinois
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • BMI between 30-40
  • weight stable (not gained/lost more than 25 lbs in the past 6 months)
  • not enrolled in any formal weight-loss program
  • interested in losing weight
  • willing and able to record dietary intake and weight for 6 months and wear an accelerometer
  • willing to attend 8 weekly groups and 2 follow up assessments at the Northwestern Chicago campus
  • expect to reside in the Chicago land area for the next 12 months

Exclusion Criteria:

  • any unstable medical conditions (i.e. uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, a cerebrovascular accident within the past 6 months)
  • history of insulin-dependent diabetes
  • Crohn's disease
  • diagnosis of obstructive sleep apnea requiring intervention
  • required use of an assistive device for mobility (i.e. cane, wheelchair)
  • BMI > 40
  • hospitalization for a psychiatric disorder within the past 5 years
  • those at risk for adverse cardiovascular events with moderate intensity activity
  • those currently taking weight loss medication or committed to following an incompatible dietary regimen
  • women who are pregnant, trying to get pregnant, or lactating
  • Bulimia Nervosa
  • suicide ideation
  • current binge eating disorder
  • those currently taking medications known to cause weight gain (i.e. Prednisone, Depakote, Diebeta, Diabinese, Cardura, Inderal, Zyprexa)
  • current substance abuse or dependence
  • plantar fasciitis
  • current substance and/or alcohol dependence
  • depression
  • ADHD

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
Behaviorální: Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
Experimentální: Technology Supported condition
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
Behaviorální: Technology Supported
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
Žádný zásah: Self-Guided
Participants in the Self-Guided condition will receive DPP DVDs (3 DVDs and 1 CD) at the beginning of the study. This condition will not receive any direct dietary or physical activity interventions outside of the DVDs. Although Self-Guided participants will be receiving the same 7% weight loss goal as the other two groups, they will not be receiving physical activity or diet goals. The DVDs cover the initial 12-weekly sessions of the DPP, with the sessions portrayed by professional actors. They will also be provided with a supplemental DVD which includes a manual for each of the 12 sessions. They will also be giving the Keeping Track booklets and asked to record their diet and activity daily.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Weight loss
Časové okno: 3 months, 6 months, 12 months
3 months, 6 months, 12 months

Sekundární výstupní opatření

Měření výsledku
Časové okno
Behavioral adherence
Časové okno: 3 months, 6 months
3 months, 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Northwestern University

Spolupracovníci

Illinois Institute of Technology

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bonnie Spring, Ph.D., Northwestern University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2011

Primární dokončení (Aktuální)

1. května 2013

Dokončení studie (Aktuální)

1. května 2013

Termíny zápisu do studia

První předloženo

15. ledna 2010

První předloženo, které splnilo kritéria kontroly kvality

15. ledna 2010

První zveřejněno (Odhad)

18. ledna 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

11. listopadu 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. listopadu 2016

Naposledy ověřeno

1. listopadu 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RC1DK087126-01 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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