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Pilot Test of a Healthy Metabolic Behaviour Tool

Primary Purpose

Metabolic Disease, Obese, Diet Habit

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
6P intervention
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disease

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

6P intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Vegetable intake
Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention
Pleasure food intake
Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention
Meal timing
Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention
Physical activity
Assessed by the duration of physical activity in the 6P tool before and after the intervention
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.

Secondary Outcome Measures

Body weight changes
Weight changes in kg before and after the intervention
Body mass index changes
Body mass index changes in kg/m2 before and after the intervention
Dietary behavioral changes
Assessed by the Three Factor Eating Questionnaire before and after the intervention
Activity intensity changes
Assessed by the International Physical activity Questionnaire
Screen viewing time changes
Assessed by the Sedentary Behavioural Questionnaire

Full Information

First Posted
September 25, 2020
Last Updated
November 18, 2021
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04582643
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Obese, Diet Habit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot test of lifestyle intervention using newly developed tool
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6P intervention
Arm Type
Experimental
Arm Description
6P assessment along with education provided based on the 6P components.
Intervention Type
Behavioral
Intervention Name(s)
6P intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Meal portion size
Description
Assessed by the portion size rating (scores1-7) in the 6P tool before and after the intervention. Higher score indicates higher portion size.
Time Frame
Between baseline and follow-up visit (1 month)
Title
Vegetable intake
Description
Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Pleasure food intake
Description
Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Meal timing
Description
Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Physical activity
Description
Assessed by the duration of physical activity in the 6P tool before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Motivational level
Description
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.
Time Frame
Between baseline and follow-up visit (1 month)
Secondary Outcome Measure Information:
Title
Body weight changes
Description
Weight changes in kg before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Body mass index changes
Description
Body mass index changes in kg/m2 before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Dietary behavioral changes
Description
Assessed by the Three Factor Eating Questionnaire before and after the intervention
Time Frame
Between baseline and follow-up visit (1 month)
Title
Activity intensity changes
Description
Assessed by the International Physical activity Questionnaire
Time Frame
Between baseline and follow-up visit (1 month)
Title
Screen viewing time changes
Description
Assessed by the Sedentary Behavioural Questionnaire
Time Frame
Between baseline and follow-up visit (1 month)
Other Pre-specified Outcome Measures:
Title
Clarify, usefulness and acceptability of the 6P tool
Description
Assessed by the feedback evaluation questionnaire
Time Frame
Follow up visit at 1 month
Title
Usefulness and acceptability for the nudges
Description
Assessed by the nudges rating scale and feedback evaluation questionnaire
Time Frame
1 month
Title
Other lifestyle changes
Description
Assessed by the general lifestyle questionnaire
Time Frame
Between baseline and follow-up visit (1 month)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women planning to conceive
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 21-40 years body mass index >= 25 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Kok Yen Chan, PhD
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Test of a Healthy Metabolic Behaviour Tool

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