Pilot Test of a Healthy Metabolic Behaviour Tool

Not Applicable

Completed

• Conditions: Metabolic Disease; Obese; Diet Habit
• Interventions: Behavioral: 6P intervention

• Registration Number: NCT04582643
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Start: 2021-07-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6P intervention	6P intervention	6P assessment along with education provided based on the 6P components.

Primary Outcome Measures

Name	Time	Method
Meal portion size	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Body mass index changes	Between baseline and follow-up visit (1 month)	Body mass index changes in kg/m2 before and after the intervention
Dietary behavioral changes	Between baseline and follow-up visit (1 month)	Assessed by the Three Factor Eating Questionnaire before and after the intervention
Body weight changes	Between baseline and follow-up visit (1 month)	Weight changes in kg before and after the intervention
Activity intensity changes	Between baseline and follow-up visit (1 month)	Assessed by the International Physical activity Questionnaire
Screen viewing time changes	Between baseline and follow-up visit (1 month)	Assessed by the Sedentary Behavioural Questionnaire

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore