Pilot Test of a Healthy Metabolic Behaviour Tool

NCT04582643 | Completed

• 1 other identifier: CIRB 2020/2530
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disease; Obese; Diet Habit

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Body weight changes

  Between baseline and follow-up visit (1 month)

• Body mass index changes

  Between baseline and follow-up visit (1 month)

• Dietary behavioral changes

  Between baseline and follow-up visit (1 month)

• Activity intensity changes

  Between baseline and follow-up visit (1 month)

• Screen viewing time changes

  Between baseline and follow-up visit (1 month)

Other Outcomes (3)

• Clarify, usefulness and acceptability of the 6P tool

  Follow up visit at 1 month

• Usefulness and acceptability for the nudges

  1 month

• Other lifestyle changes

  Between baseline and follow-up visit (1 month)

Study Arms (1)

6P intervention

EXPERIMENTAL

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

Behavioral: 6P intervention

Interventions

6P intervention 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.

6P intervention

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: women planning to conceive
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Metabolic Diseases; Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Jerry Kok Yen Chan, PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single arm pilot test of lifestyle intervention using newly developed tool

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 9, 2020
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)