Effect of Self Regulation With Mindfulness Training on Body Mass Index and Cardiovascular Risk Markers in Obese Adults
18 april 2012 uppdaterad av: Amit Sood, Mayo Clinic
Enhancing Self Regulation With Mindfulness Training and Its Effect on Body Mass Index and Cardiovascular Risk Markers in Obese Adults: A Randomized Pilot Clinical Trial
This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled trial.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Obesity is associated with deficits in self regulation.
Approaches that foster increased non-judgmental present moment awareness and increased acceptance have been demonstrated to enhance self regulation.
One commonly used approach that synthesizes these concepts is mindfulness training.
This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition, on body mass index, cardiovascular risk markers, peripheral blood telomere length and telomerase levels in obese adults.
The mindfulness training program is adapted from the Attention and Interpretation Therapy developed by study investigators at Mayo Clinic.
The study is designed as a 6-month pilot randomized controlled trial involving 40 obese adults and their partners/spouses with standard dietary counseling as the control intervention.
Promising feasibility and efficacy data from the study will prompt us to pursue a larger, multi-center trial to more definitively test this program as well as apply this intervention in clinical practice.
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
PRIMARY PARTICIPANT
Inclusion Criteria:
- Obese adults (BMI ≥ 30)
- Currently working at Mayo Clinic Rochester
- Able to provide informed consent
- Stable weight (within + 10 pounds) during the three months prior to enrolling in the study
Exclusion Criteria:
- Currently (in the past six months) attending a weight loss program
- Underlying genetic or endocrine cause for weight gain
- Current cancer
- Medications known to affect weight (corticosteroids, antidepressants, anti psychotics, mood stabilizers, and anti-epileptic medications)
- Musculoskeletal conditions affecting the ability to adequately perform general physical activity
- Active smoking
- Substance abuse
- Quitting smoking within 6 months of enrolling in the study
- Have clinically significant acute unstable neurological, psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
- Have an established practice of meditation for three or more months
- Not willing to complete study outcome measures.
PARTNER/SPOUSE
Inclusion Criteria:
- Able to provide informed consent
Exclusion Criteria:
- Have clinically significant acute unstable neurological,Psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
- Have an established practice of meditation for three or more months
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Dietary Counseling
The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.
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The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.
|
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Övrig: Mindfulness Training Program
The mindfulness training program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
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The mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline to a healthier lifestyle.
Tidsram: 6 Months
|
Improvement in general health.
|
6 Months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in vital signs.
Tidsram: 6 Months
|
Body mass index (BMI) and absolute and percentage weight loss will be compared.
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6 Months
|
|
Change from baseline in laboratory values.
Tidsram: 6 Months
|
Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.
|
6 Months
|
|
Change from baseline in stress management.
Tidsram: 6 Months
|
Stress, anxiety, and quality of life will be measured on various study questionnaires.
|
6 Months
|
|
Change in baseline on different aspects of eating.
Tidsram: 6 Months
|
Mindful eating, self efficacy and self regulation in eating will be compared.
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6 Months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Amit Sood, MD, Mayo Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2011
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
1 april 2012
Studieregistreringsdatum
Först inskickad
13 juni 2011
Först inskickad som uppfyllde QC-kriterierna
16 juni 2011
Första postat (Uppskatta)
17 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 april 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 april 2012
Senast verifierad
1 april 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11-001775
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 .