Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Lifestyle Changes Through Exercise and Nutrition (LEAN)

4 giugno 2018 aggiornato da: Robert L. Newton, Jr., Pennington Biomedical Research Center

The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project

The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The LEAN Project is a community-based weight loss program that is delivered through churches serving lower-income, obese, African American adults. The intervention will involve training community health coaches to deliver the intervention. These community health coaches will be individuals who are members of the church and who are willing to be trained on how to deliver behaviorally-based, empirically proven, lifestyle change interventions. These community health coaches will be trained by the staff at Pennington Biomedical, who have experience training and delivering these types of interventions. The community health coaches will deliver the intervention through their respective church after being trained. Weekly text messages will be sent to participants in order to supplement the intervention sessions and provide support. The primary aim is to determine if the trained community health coach church-based intervention will result in significant weight loss. Secondary aims will assess blood glucose, cholesterol, physical activity, food intake, and weight related quality of life.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

97

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Pennington Biomedical Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • self-identify as African American
  • a member of a participating church
  • age 18-75 years old
  • BMI > 30
  • own a mobile phone with text message capabilities
  • at risk for diabetes (diagnosed nuclear family member or gestational diabetes) or diagnosed with type 2 diabetes
  • willing to provide written informed consent
  • willing to change diet, physical activity and weight
  • able to participate in face-face counselling sessions as scheduled
  • low to moderate cardiovascular disease risk

Exclusion Criteria:

  • currently participating in a weight loss program
  • currently using weight loss medication or have lost weight (>10 lbs in last year)
  • planning to move from the area within the next year
  • given birth within the past year, are currently pregnant or plan to become pregnant within the next year
  • planning to have bariatric surgery within 2 years
  • history of major depression, suicidal behavior or eating disorder
  • hospitalization for a mental disorder or substance abuse in the last year
  • have cancer or had cancer within the past 5 years.
  • serious heart problems such as arrhythmias, cardiomyopathy, congestive heart failure
  • stroke or heart attack in the last six months
  • high blood pressure [systolic ≥160, or diastolic ≥100]
  • chronic inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease
  • diseases that are life threatening or that can interfere with or be aggravated by exercise or weight loss
  • unwilling or unable to provide informed consent
  • physician's or principal investigator's decision to exclude

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Weight loss intervention
Churches randomized to the intervention condition will receive the community health coach delivered church based intervention for 6 months followed by 6 months of weight maintenance.
Comportamentale: Weight loss intervention
The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
Sperimentale: Delayed Treatment Control Group
Churches in the delayed treatment control condition will receive information on various health topics relevant to African Americans, such as strokes, lupus, sickle cell, etc. via text message during the first six months. Participants in this group will not receive any behavioral strategies designed to alter weight, physical activity, or diet during this time. They will receive the community health coach delivered church based weight loss intervention after 6 months.
Comportamentale: Weight loss intervention
The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent weight loss
Lasso di tempo: Month 6 and Year 1
Percent weight loss will be calculated at 6 and 12 months.
Month 6 and Year 1

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Fat Percentage
Lasso di tempo: Screening, Month 6 and Year 1
The participant's body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240).
Screening, Month 6 and Year 1
Change in Blood Glucose
Lasso di tempo: Screening, Month 6 and Year 1
The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible glucose testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
Screening, Month 6 and Year 1
Change in Blood Pressure
Lasso di tempo: Screening, Month 6 and Year 1
Blood pressure will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to blood pressure measurement to ensure accurate at rest reading.
Screening, Month 6 and Year 1
Change in Food Intake
Lasso di tempo: Screening, Month 6 and Year 1
The National Cancer Institute (NCI) fat screener estimates the percentage of energy from fat by asking patients to report the frequency of consuming specific foods over the past 12 months. A standard 7-item fruit and vegetable screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and vegetables were consumed in the past month.
Screening, Month 6 and Year 1
Change in Physical activity
Lasso di tempo: Screening, Month 6 and Year 1
The International Physical Activity Questionnaire (IPAQ) questionnaire is a self-report measure of physical activity. The metabolic equivalent task (MET) minutes in each domain of leisure time activity, that is, sedentary, light, moderate, and vigorous intensity, will be calculated. The IPAQ has been shown to be a reliable and valid measure of physical activity and has been sensitive to changes in physical activity resulting from intervention programs.
Screening, Month 6 and Year 1
Change in Quality of Life
Lasso di tempo: Screening, Month 6 and Year 1
. Each participant's quality of life will be assessed using the Impact of Weight on Quality of Life Survey.
Screening, Month 6 and Year 1
Satisfaction Questionnaire
Lasso di tempo: Month 6 and Year 1
Each participant's satisfaction with the different elements of the study, including the community health coaches, the intervention, and the text messages, will be measured using a questionnaire developed by the investigators.
Month 6 and Year 1
Change in Blood Cholesterol
Lasso di tempo: Screening, Month 6 and Year 1
The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible cholesterol testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
Screening, Month 6 and Year 1
Change in Pulse
Lasso di tempo: Screening, Month 6 and Year 1
Pulse will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to pulse measurement to ensure accurate at rest reading.
Screening, Month 6 and Year 1

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pennington Biomedical Research Center

Investigatori

  • Investigatore principale: Robert L Newton, Jr., PhD, Pennington Biomedical Research Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2016

Completamento primario (Effettivo)

23 settembre 2017

Completamento dello studio (Effettivo)

23 settembre 2017

Date di iscrizione allo studio

Primo inviato

7 luglio 2016

Primo inviato che soddisfa i criteri di controllo qualità

8 agosto 2016

Primo Inserito (Stima)

11 agosto 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • PBRC 2016-018

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Weight loss intervention

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Myanmar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi