Clinical trial NCT04582643: Pilot Test of a Healthy Metabolic Behaviour Tool
Official title: Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Obese
Diet Habit
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2020-10-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot test of lifestyle intervention using newly developed tool
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Meal portion size
timeFrame: Between baseline and follow-up visit (1 month)
measure: Vegetable intake
timeFrame: Between baseline and follow-up visit (1 month)
measure: Pleasure food intake
timeFrame: Between baseline and follow-up visit (1 month)
measure: Meal timing
timeFrame: Between baseline and follow-up visit (1 month)
measure: Physical activity
timeFrame: Between baseline and follow-up visit (1 month)
measure: Motivational level
timeFrame: Between baseline and follow-up visit (1 month)
Secondary outcomes:
measure: Body weight changes
timeFrame: Between baseline and follow-up visit (1 month)
measure: Body mass index changes
timeFrame: Between baseline and follow-up visit (1 month)
measure: Dietary behavioral changes
timeFrame: Between baseline and follow-up visit (1 month)
measure: Activity intensity changes
timeFrame: Between baseline and follow-up visit (1 month)
measure: Screen viewing time changes
timeFrame: Between baseline and follow-up visit (1 month)
Other outcomes:
measure: Clarify, usefulness and acceptability of the 6P tool
timeFrame: Follow up visit at 1 month
measure: Usefulness and acceptability for the nudges
timeFrame: 1 month
measure: Other lifestyle changes
timeFrame: Between baseline and follow-up visit (1 month)
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Jerry Kok Yen Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: