Pilot Test of a Healthy Metabolic Behaviour Tool

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04582643
Collaborator
(none)
50
1
1
3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 6P intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm pilot test of lifestyle intervention using newly developed toolSingle arm pilot test of lifestyle intervention using newly developed tool
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6P intervention

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. Body weight changes [Between baseline and follow-up visit (1 month)]

    Weight changes in kg before and after the intervention

  2. Body mass index changes [Between baseline and follow-up visit (1 month)]

    Body mass index changes in kg/m2 before and after the intervention

  3. Dietary behavioral changes [Between baseline and follow-up visit (1 month)]

    Assessed by the Three Factor Eating Questionnaire before and after the intervention

  4. Activity intensity changes [Between baseline and follow-up visit (1 month)]

    Assessed by the International Physical activity Questionnaire

  5. Screen viewing time changes [Between baseline and follow-up visit (1 month)]

    Assessed by the Sedentary Behavioural Questionnaire

Other Outcome Measures

  1. Clarify, usefulness and acceptability of the 6P tool [Follow up visit at 1 month]

    Assessed by the feedback evaluation questionnaire

  2. Usefulness and acceptability for the nudges [1 month]

    Assessed by the nudges rating scale and feedback evaluation questionnaire

  3. Other lifestyle changes [Between baseline and follow-up visit (1 month)]

    Assessed by the general lifestyle questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • age 21-40 years

  • body mass index >= 25 kg/m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hospital Singapore Singapore

Sponsors and Collaborators

  • KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Jerry Kok Yen Chan, PhD, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT04582643
Other Study ID Numbers:
  • CIRB 2020/2530
First Posted:
Oct 9, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021