- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01134783
Choosing Healthy Options in College Environments and Settings (CHOICES)
Evaluating Innovative Weight Reduction Strategies for College Students
Visão geral do estudo
Descrição detalhada
The goal of this research is to develop and test innovative strategies to help prevent unhealthy weight gain in college students attending 2-year community or technical colleges. The intervention we propose for Phase 2, and will refine through our formative experiences in Phase 1, will be based on social ecological and social networks models with students randomized to conditions. Students (n=440) with BMIs between 20.0 and 34.9 will be recruited to participate in an intervention trial that lasts 24 months. After the initial screening and consent procedures, students will complete baseline measures that include: assessment of body composition; blood pressure and a blood draw; a behavioral and psychosocial survey; medical and weight history and two 24-hour online dietary recalls. After the completion of baseline assessments, students will be randomized into treatment or control conditions. Students randomized into the intervention condition will participate in a 1-credit course offered through their 2-year college that focuses on eating, activity, sleep and stress management as ways to help maintain or achieve a healthy weight; three course sections will be offered to accommodate students' scheduling needs and learning preferences. A web-based social network and support component will be introduced as part of this course and will continue as the intervention channel for 20 months following the 1-credit course. This supported intervention phase will use a study-designed website to reinforce, inform and encourage exchange and support between all intervention participants. Students will be asked to track their weight and weight-control behaviors on the website and intervention staff will interact with participants electronically or through phone calls offering encouragement and helping with problem solving. Control students will receive their health assessments and usual care including existing public health information on maintaining a healthy weight and information regarding health services offered on their school's campus. The effectiveness and sustainability of the intervention approaches will be evaluated.
The primary aim is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect BMI in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment, as compared to students randomized to the control condition.
The secondary aims of this study are to: 1) Examine the effectiveness of a weight gain prevention intervention to positively affect weight in 2-year college students' and 2) compare the effects of the intervention and control groups with regard to change in BMI and weight from baseline to four months and from baseline to 12 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Minnesota
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Anoka Ramsey Community College
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Inver Grove Heights, Minnesota, Estados Unidos, 55076
- Inver Hills Community College
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St. Paul, Minnesota, Estados Unidos, 55102
- Saint Paul College
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18-35 years
- Intending to be available for a 24 month intervention
Exclusion Criteria:
- Unable to provide informed consent
- BMI < 18.5 kg/m2, >/=35 kg/m2
- Household member on study staff
- Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/physical activity/weight loss intervention study
- Regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected). "Regular use" is defined as "taking this medication most days of the week for the previous month"
- Current treatment for an eating disorder
- Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
- Current treatment for malignancy (other than non-melanoma skin cancer)
- Investigator discretion
- Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months.
- Systolic BP at screening >/= 160 mmHg or diastolic BP >/= 100 mmHg. If BP exceeds this level, participants can return for re-screening after being evaluated and treated for hypertension.
- Weight loss of more than 15 lbs over the past three months
- Trying to gain weight.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention Group
The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
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Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
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Sem intervenção: Control Group
Control group (serving as a comparison group)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Body Mass Index (BMI)
Prazo: Baseline to 24 Months
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The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students.
Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.
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Baseline to 24 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Prevalence of Overweight/Obese
Prazo: Baseline to 24 Months
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The prevalence of overweight/obese between intervention and control students
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Baseline to 24 Months
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Change in BMI From Baseline to 4 Months
Prazo: Baseline to 4 Months
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Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months
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Baseline to 4 Months
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Change in Weight From Baseline to 4 Months
Prazo: Baseline to 4 Months
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Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months
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Baseline to 4 Months
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Change in BMI From Baseline to 12 Months
Prazo: Baseline to 12 Months
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Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months
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Baseline to 12 Months
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Change in Weight From Baseline to 12 Months
Prazo: Baseline to 12 Months
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Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months
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Baseline to 12 Months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Melissa N. Laska, PhD, RD, University of Minnesota
Publicações e links úteis
Publicações Gerais
- Lytle LA, Laska MN, Linde JA, Moe SG, Nanney MS, Hannan PJ, Erickson DJ. Weight-Gain Reduction Among 2-Year College Students: The CHOICES RCT. Am J Prev Med. 2017 Feb;52(2):183-191. doi: 10.1016/j.amepre.2016.10.012. Epub 2016 Dec 6.
- Laska MN, Lytle LA, Nanney MS, Moe SG, Linde JA, Hannan PJ. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population. Prev Med. 2016 Aug;89:230-236. doi: 10.1016/j.ypmed.2016.06.001. Epub 2016 Jun 7.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 0908S71521
- 1U01HL096767 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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University of VirginiaConcluídoLesão da medula espinal | Úlceras de pressãoEstados Unidos
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Charles G. ProberStanford University; Heidelberg University; University of Stellenbosch; University...ConcluídoAleitamento Materno Exclusivo | Práticas de alimentação infantilÁfrica do Sul
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University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ConcluídoDor | Cuidado paliativo | Distúrbios da Retenção Cognitiva | Outra doença crônicaEstados Unidos
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Brigham and Women's HospitalUniversity of Colorado, DenverConcluídoDiabetes Mellitus GestacionalEstados Unidos
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LuciLabCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal; Sojecci...ConcluídoComportamento de risco | Declínio CognitivoCanadá