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临床试验/NCT04373434
NCT04373434已完成不适用

A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers

Emory University1 个研究点 分布在 1 个国家目标入组 512 人开始时间: 2020年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
512
试验地点
1
主要终点
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)

研究概览

简要总结

This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

详细描述

It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.

Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.

The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 to 70 years of age
  • •able to speak English
  • •self-report BMI of 20 and above

排除标准

  • •pregnant women
  • •only one member per household will be enrolled

研究组 & 干预措施

Healthy Homes/Healthy Families (HH/HF) Intervention

Experimental

Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.

干预措施: Health Homes/Healthy Families (HH/HF) Intervention (Behavioral)

Control

Active Comparator

Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.

干预措施: Control (Behavioral)

结局指标

主要结局

Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)

时间窗: Baseline, Month 4, Month 9

Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).

Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)

时间窗: Baseline, Month 4, Month 9

Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).

次要结局

  • Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8(Baseline, Month 4, Month 9)
  • Change in Kcal Per Day Intake(Baseline, Month 4, Month 9)
  • Change in Self-reported Weight(Baseline, Month 4, Month 9)
  • Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK(Baseline, Month 4, Month 9)
  • Changes to Food Environment: HEALTHY FOOD PREPARATION(Baseline, Month 4, Month 9)
  • Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK(Baseline, Month 4, Month 9)
  • Changes to Food Environment: Family Eating and TV(Baseline, Month 4, Month 9)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle C. Kegler

Professor

Emory University

研究点 (1)

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