Metabolic DiseaseNCT04582643
Pilot Test of a Healthy Metabolic Behaviour Tool
A study testing 6P intervention in people with Metabolic Disease and Obese, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Obese, Diet Habit
- What is being tested?
- 6P intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 21-40 years
- body mass index >= 25 kg/m2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women
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.
Read the 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.
- Conditions
- Metabolic Disease, Obese, Diet Habit
- Being tested
- 6P intervention
- Medical subject headings
- Metabolic Diseases, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6P interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 6P intervention | Experimental | 6P assessment along with education provided based on the 6P components. Receives: Behavioral: 6P intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Between baseline and follow-up visit (1 month)
Secondary outcomes (5)
Body weight changes
Weight changes in kg before and after the intervention
Measured: Between baseline and follow-up visit (1 month)
Body mass index changes
Body mass index changes in kg/m2 before and after the intervention
Measured: Between baseline and follow-up visit (1 month)
Dietary behavioral changes
Assessed by the Three Factor Eating Questionnaire before and after the intervention
Measured: Between baseline and follow-up visit (1 month)
Activity intensity changes
Assessed by the International Physical activity Questionnaire
Measured: Between baseline and follow-up visit (1 month)
Screen viewing time changes
Assessed by the Sedentary Behavioural Questionnaire
Measured: Between baseline and follow-up visit (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot test of lifestyle intervention using newly developed tool
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jerry Kok Yen Chan, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582643
- Sponsor's protocol ID
- CIRB 2020/2530
- Status last verified
- Nov 2021
- First submitted
- 25 Sep 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT04582643
- Acronym / sponsor ID
- CIRB 2020/2530
- Conditions
- Metabolic Disease, Obese, Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot test of lifestyle intervention using newly developed tool
| Arm | Type | Receives |
|---|---|---|
| 6P intervention | Experimental | Behavioral: 6P intervention6P assessment along with education provided based on the 6P components. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 21-40 years
- body mass index >= 25 kg/m2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6P intervention6P 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. | Behavioural | 6P intervention |
Primary outcome
Meal portion size
Time frame: 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.
Vegetable intake
Time frame: 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
Pleasure food intake
Time frame: 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
Meal timing
Time frame: 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
Physical activity
Time frame: Between baseline and follow-up visit (1 month)
Assessed by the duration of physical activity in the 6P tool before and after the intervention
Motivational level
Time frame: 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.
5 secondary outcomes
Body weight changes
Time frame: Between baseline and follow-up visit (1 month)
Body mass index changes
Time frame: Between baseline and follow-up visit (1 month)
Dietary behavioral changes
Time frame: Between baseline and follow-up visit (1 month)
Activity intensity changes
Time frame: Between baseline and follow-up visit (1 month)
Screen viewing time changes
Time frame: Between baseline and follow-up visit (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Kok Yen Chan, PhD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6P intervention in people with Metabolic Disease and Obese, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meal portion size (time frame: Between baseline and follow-up visit (1 month)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.