Pilot Test of a Healthy Metabolic Behaviour Tool

Study 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.

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

Conditions
-----------------
Metabolic Disease, Obese, Diet Habit

Intervention / Treatment
-----------------
* Behavioral: 6P intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 21-40 years body mass index >= 25 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot test of lifestyle intervention using newly developed tool
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6P intervention<br>6P assessment along with education provided based on the 6P components. | Behavioral: 6P intervention<br>* 6P assessment targeting on diet, activity and mentality, along with education provided based on the 6P components. The 6P tool serves the functions to help the women to self-monitor and be aware of their negative lifestyle choices.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal portion size | Assessed by the portion size rating (scores1-7) in the 6P tool before and after the intervention. Higher score indicates higher portion size. | Between baseline and follow-up visit (1 month) | 
| Vegetable intake | Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention | Between baseline and follow-up visit (1 month) | 
| Pleasure food intake | Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention | Between baseline and follow-up visit (1 month) | 
| Meal timing | Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention | Between baseline and follow-up visit (1 month) | 
| Physical activity | Assessed by the duration of physical activity in the 6P tool before and after the intervention | Between baseline and follow-up visit (1 month) | 
| Motivational level | 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. | Between baseline and follow-up visit (1 month) | 

Secondary Outcome Measures

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