Translation of Obesity & Cognitive Program by Lay Health Educators

Status Completed

Clinical Trial Summary

Obesity is a major public health problem among older adults, with 31% of non-institutionalized older persons (60 years+) in the US obese and projections indicating that this will rise to 40% by 2010. A second public health challenge on the horizon for the aging US population is the increasing number of individuals experiencing cognitive decline, dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in reducing risks associated with both of these significant and increasingly pervasive health problems, which are more common among rural, low income and ethnic minority populations. The Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in a large, diverse population of high-risk individuals and dramatically reduced rates of type 2 diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory in community dwelling older persons. Transferring these exciting technologies to community settings where they can benefit older adults is a pressing public health need. Therefore, the current project seeks to transfer these two evidence-based interventions to older adults in a rural state using senior centers as the venue for dissemination and lay health educators to deliver the interventions. Senior centers are a particularly attractive context for translation of evidence-based health promotion technologies in predominantly rural states like Arkansas because they have a well-established infrastructure in communities and share a common goal of promoting healthy aging and reducing health care costs. The 3-year randomized, controlled trial will evaluate translation of the interventions by randomizing senior centers (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program. Older (age > 60) adults (N=288) nested within senior centers will receive the programs delivered in a group format by a trained lay health educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months. The multi-level evaluation plan will characterize reach, effectiveness, adoption, implementation and maintenance of the interventions, with a cost effectiveness component.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01377506
Study type	Interventional
Source	University of Arkansas
Contact
Status	Completed
Phase	N/A
Start date	September 2007
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Terminated	`NCT03299881` - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss	N/A
Completed	`NCT02805478` - Fat-Associated Cardiovascular Organ Dysfunction
Active, not recruiting	`NCT02558920` - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Completed	`NCT03759743` - Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject	N/A
Completed	`NCT03610958` - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.	N/A
Completed	`NCT03678766` - CHARGE: Controlling Hunger and ReGulating Eating	N/A
Completed	`NCT04430465` - Effects of Wholegrains on Children's Health (KORN)	N/A
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT05376865` - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers	N/A
Completed	`NCT03625427` - Effect of Palmitoleic Acid on C-reactive Protein	N/A
Active, not recruiting	`NCT03435445` - Online Platform for Healthy Weight Loss (POEmaS)	N/A
Enrolling by invitation	`NCT05576116` - Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics	N/A
Recruiting	`NCT05249465` - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention	N/A
Active, not recruiting	`NCT06023095` - A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities	Phase 1
Completed	`NCT03648892` - Brain Dopamine Function in Human Obesity	Early Phase 1
Recruiting	`NCT02887950` - Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause	N/A
Terminated	`NCT02796144` - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia	Phase 4
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02899390` - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Translation of Obesity and Cognitive Program by Lay Health Educators — Coaches

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms