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Pilot Test of a Healthy Metabolic Behaviour Tool

NCT ID: NCT04582643

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Metabolic Disease Obese Diet Habit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm pilot test of lifestyle intervention using newly developed tool
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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6P intervention

6P assessment along with education provided based on the 6P components.

Group Type EXPERIMENTAL

6P intervention

Intervention Type BEHAVIORAL

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.

Interventions

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6P intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerry Kok Yen Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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CIRB 2020/2530

Identifier Type: -

Identifier Source: org_study_id