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临床试验/NCT04582643
NCT04582643已完成不适用

Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Meal portion size

研究概览

简要总结

This study aims to validate and pilot test the short-term intervention effect of a newly developed healthy metabolic behaviour tool, named as the 6P tool, on dietary attitude/ practice and body weight changes over one month among overweight and obese women. A total of 50 women, aged 21-40 years, BMI ≥25 kg/m2, who are attending the preconception clinic and planning for a pregnancy over the next one year, will be invited to participate in this pilot study. The recruitment period is estimated to take up to 10 weeks, with subsequent 1 month follow-up visit.

详细描述

Preconception is a stage that could critically influence subsequent antenatal and postnatal health of mother and offspring. In Singapore, approximately one-third of women are overweight and obese during the preconception period. In the present pilot study, the investigators aim to introduce a simple, self-administered tool that can identify discrete components of an individual's diet, which would lead to self-awareness, self-evaluation and self-education, and over time, results in a positive change in eating habits and health. Specifically, the study aims i) to validate a newly developed tool that comprises six main dietary components (6P), namely Portion, Proportion, Pleasure, Phase, Physicality and Psychology in overweight and obese women during the preconception period; (ii) and to assess the short-term intervention effect of the 6P tool on dietary attitude/ practice and body weight changes over one month. The investigators hypothesise that intervention using this 6P tool in overweight and obese women will help them to promote healthy eating behaviours and reduce body weight. This study targets to recruit 50 overweight/ obese preconception women, from KK Women's and Children's Hospital, to evaluate the effectiveness of the tool over one month. Throughout the one month follow up period, nudges in the form of text messages/images related to the 6P goals will be sent to participants through mobile phone. This validated 6P tool is planned to be applied in a preconception targeted intervention cohort in order to build a positive mental model in healthy eating among overweight and obese women, enhancing awareness and belief towards weight management behaviour, and promoting a healthy life cycle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 21-40 years
  • body mass index >= 25 kg/m2

排除标准

  • 未提供

结局指标

主要结局

Meal portion size

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the portion size rating (scores1-7) in the 6P tool before and after the intervention. Higher score indicates higher portion size.

Vegetable intake

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention

Pleasure food intake

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention

Meal timing

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention

Physical activity

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the duration of physical activity in the 6P tool before and after the intervention

Motivational level

时间窗: Between baseline and follow-up visit (1 month)

Assessed by the rating of motivational level (scores 1-9) in the 6P tool before and after the intervention. Higher score indicates higher motivational level.

次要结局

  • Body mass index changes(Between baseline and follow-up visit (1 month))
  • Dietary behavioral changes(Between baseline and follow-up visit (1 month))
  • Body weight changes(Between baseline and follow-up visit (1 month))
  • Activity intensity changes(Between baseline and follow-up visit (1 month))
  • Screen viewing time changes(Between baseline and follow-up visit (1 month))

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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