Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/12/2016
Date assigned
20/01/2017
Last edited
19/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and aims:
Obesity is a growing problem worldwide, putting people at risk of serious medical conditions such as diabetes and heart disease. Studies have shown that when parents are overweight, their children can also become overweight. Healthy Dads, Healthy Kids is a weight management program developed in Australia. It was developed looking at families as a whole, so that changes in the men’s health behaviours would positively impact on their children and the children help their ‘father’ to maintain his behaviour change. Whilst the program has been tested in Australia, it is unknown as to whether it would work in a multi-ethnic UK setting. The aim of Healthy Dads, Healthy Kids UK is to modify an existing weight management and healthy lifestyle program for fathers and their children (aged 4-11 years) so that it is culturally acceptable in a UK multi-ethnic population. The aim of this study is to find out if the Healthy Dads, Healthy Kids program can be acceptable in a UK setting.

Who can participate?
Obese men who are the fathers of primary school aged children (4-11 years) and their children.

What does the study involve?
This study involves two phases. In the first phase, 30 fathers and their children take part in the Healthy Dads, Healthy Kids program. This involves attending nine 90-minute sessions once a week for nine weeks. Mothers/partners are invited to attend one session, and fathers and children attend all nine sessions. The sessions involve discussion and family-based physical activity. Parents and the children are given interactive resources such as manuals, log books, playing cards and an activity chart to encourage learning. The family is given a family voucher to attend a leisure centre for swimming or other family activities will be provided free for one occasion. Before and after the program, fathers and their children are weighed and complete questionnaires about their diet and exercise habits.
In the second phase of the study, 90 fathers and their children are randomly allocated to one of two groups. Those in the first group take part in the Healthy Dads, Healthy Kids program in the same way as those in the first phase of the study. Those in the second group are provided with details about local opportunities for physical activity. Before the program and then after three and six months, fathers and their children are weighed and complete questionnaires about their diet and exercise habits. In addition, the amount of families that take part and who stay in the study until the end are recorded.

What are the possible benefits and risks of participating?
Fathers who take part may benefit from losing weight. Families as a whole may benefit from improving their diets and getting more exercise, which is beneficial for health. There are no notable risks involved with participating in this study.

Where is this study run from?
1. Sandwell Metropolitan Borough Council (UK)
2. Wolverhampton City Council (UK)

When is this study starting and how long is it expected to run for?
May 2016 to September 2018

Who is funding the study?
National Institute of Health Research (UK)

Who is the main contact?
1. Professor Kate Jolly (scientific)
c.b.jolly@bham.ac.uk
2. Dr Manbinder Sidhu (public)
m.s.sidhu@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kate Jolly

ORCID ID

Contact details

Public Health Building
Institute of Applied Health Research
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Type

Public

Additional contact

Dr Manbinder Sidhu

ORCID ID

Contact details

University of Birmingham
Murray Learning Centre
Institute of Applied Health Research
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 1214 147895
m.s.sidhu@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHR Project: 14/185/13

Study information

Scientific title

Healthy Dads, Healthy Kids UK: a cultural adaptation and feasibility study of a weight management programme for fathers of younger children

Acronym

Healthy Dads, Healthy Kids UK (HDHK)

Study hypothesis

The overall aim of this study is to modify an existing weight management and healthy lifestyle programme for fathers and their children (aged 4-11 years) so that it is culturally acceptably in a UK multi-ethnic population.

Ethics approval

University of Birmingham research governance department, 16/01/2017, ref: ERN_16-1323

Study design

Phase 1: Uncontolled non-randomised study
Phase 2: Randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Phase 1:
30 fathers and their children receive the HDHK intervention. This involves nine 90-minute sessions delivered at weekly intervals. Fathers and children will attend all nine sessions, with the mothers/partners being invited to attend one session. The sessions include topics such as appropriate portion sizes for family mealtimes, eating a healthy diet, better understanding of parenting, family orientated physical activities, reducing screen time, as well as tips for staying on track after the program finishes.
The nine sessions begin with fathers and children together (15 minutes) setting/reviewing weekly goals, then separate groups (30 minutes) to talk about healthy living, finishing with a physical activity session in family groups (45 minutes).

Follow up will be completed pre and post intervention.

Phase 2:
90 families (fathers and children) will be stratified by site and ethnicity in ratio 2:1 using block randomisation.

Usual care: Fathers are provided with information on local opportunities for physical activity and a free family entry to a leisure centre.

Intervention: Fathers and their children receive the HDHK intervention. This involves nine 90-minute sessions delivered at weekly intervals. Fathers and children will attend all nine sessions, with the mothers/partners being invited to attend one session. The sessions include topics such as appropriate portion sizes for family mealtimes, eating a healthy diet, better understanding of parenting, family orientated physical activities, reducing screen time, as well as tips for staying on track after the program finishes.
The nine sessions begin with fathers and children together (15 minutes) setting/reviewing weekly goals, then separate groups (30 minutes) to talk about healthy living, finishing with a physical activity session in family groups (45 minutes).

Follow up will be conducted at 3 and 6 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility outcomes:
1. Recruitment rate is measured using patient demographic data on reply slip at baseline
2. Attendance rate is measured using patient demographic data on attendance sheet at each week of intervention
3. Attrition rate is measured using patient demographic data on attendance sheets and questionnaires at the end of intervention and follow up
4. Acceptability of delivering the adapted intervention programme to a multi-ethnic population is measured using qualitative methods (interviews and observations) during and after intervention up to 6 month follow-up

Secondary outcome measures

Fathers:
1. Weight is measured using Tanita scales (Kg) at baseline and 6 months
2. % losing ≥5% body mass is measured using Tanita scale at baseline and 6 months
3. Waist circumference (cm) measured at baseline and 6 months
4. % body fat is measured using Tanita scales at baseline and 6 months
5. Self-reported physical activity measured by the IPAQ-short at baseline, 3 and 6 months
6. Objectively measured physical activity measured by a GENEactiv accelerometer at baseline and 6 months
7. Self-reported dietary intake is measured using frequencies of indictor foods and eating behaviours at baseline, 3 and 6 months
8. Father involvement is measured using the Parent-Child Relationships Questionnaire at baseline, 3 and 6 months
9. Parenting for physical activity using the physical activity items from the ‘Parenting Strategies for Eating and Activity Scale’ at baseline, 3 and 6 months
10. General quality of life is measured by the EQ-5D-5L at baseline, 3 and 6 months
11. Health care utilisation is measured using the ICECAP at baseline, 3 and 6 months

Children:
1. Children’s BMI z-score is calculated using weight and height measurements at baseline and 6 months
2. % body fat is measured using Tanita scales at baseline and 6 months
3. % categorised as overweight or obese is measured using Tanita scales at baseline and 6 months
4. Parent-reported dietary intake for eldest child in study is measured using frequencies of indictor foods and eating behaviours at baseline, 3 and 6 months
5. Objectively measured physical activity (eldest child in study) is measured using Geneactive accelerometers at baseline and 6 months
6. The feasibility of collecting educational attainment will be explored at baseline and 6 months
7. Paediatric quality of life is measured using CHU-9D at baseline and 6 months

Overall trial start date

01/05/2016

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese men who are fathers/step-fathers/male role models (e.g. grandfather, uncle) of primary school aged children (4-11 years)
2. Men must be aged between 18-65 years with a BMI of 30-40kg/m2 (27.5-40kg/m2 for MEGs) and want to lose weight
3. Fathers may be co-resident or not resident with their children

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

120 fathers and their children

Participant exclusion criteria

1. Fathers who suffer with angina or other cardiovascular disease, orthopaedic or joint problems that would be a barrier to vigorous physical activity
2. Fathers who have had a weight loss of 3kg or 7lbs in the last 3 months
3. Fathers who have answered a positive response to any question in the physical activity readiness questionnaire (PAR-Q)
4. A father, who is diabetic requiring treatment with insulin, who does not sign a health commitment statement taking personal responsibility for their condition and ability to self-manage their diabetes with increased exercise

Recruitment start date

10/01/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sandwell Metropolitan Borough Council
Sandwell Council House Freeth Street
Oldbury
B69 3DE
United Kingdom

Trial participating centre

Wolverhampton City Council
Civic Centre St Peter’s Square
Wolverhampton
WV1 1SH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Research Governance Department
Aston Webb Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Kate Jolly (c.b.jolly@bham.ac.uk) or Dr Manbinder Sidhu, (m.s.sidhu@bham.ac.uk).

Intention to publish date

28/02/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes