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Clinical Trials/NCT04582643
NCT04582643
Completed
Not Applicable

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

KK Women's and Children's Hospital1 site in 1 country50 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Disease
Sponsor
KK Women's and Children's Hospital
Enrollment
50
Locations
1
Primary Endpoint
Meal portion size
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
KK Women's and Children's Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Meal portion size

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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