A pilot study to assess whether delivery of a health and well-being programme set within a community based football club is feasible and acceptable to hard to reach men

A pilot randomised controlled trial to assess feasibility and acceptability of a behavioural intervention targeting physical and mental health of hard to reach men via a football club - the 12th Man

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14046627

Enrollment

Registered

2019-08-22

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical and mental health Not Applicable

Interventions

The proposed study is not disease-specific. Men aged between 30 and 65 years who are free from any condition that would prevent or restrict them from participating in physical activity are the focus o

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Men 2. Aged 30 – 65 years 3. Consent to randomisation

Exclusion criteria

Exclusion criteria: 1. Failure to return pre-screening questionnaire 2. Condition or disability which would prevent participation in physical activity or exercise

Design outcomes

Primary

Measure	Time frame
1. Feasibility and acceptability: 1.1. Feasibility assessed by recording recruitment, retention and adherence rates of study participants including willingness to be randomised 1.2. Acceptability assessed qualitatively via focus group discussions upon completion of the study Outcomes measured at baseline, immediately post intervention, and 6 and 12 months post intervention	—

Secondary

Measure	Time frame
Measured at baseline, immediately post intervention, and 6 and 12 months post intervention: 1. Fasting measures of plasma, serum or whole blood insulin, glucose, non-esterfied fatty acids, interleukin-6, tumour necrosis factor alpha, C-reactive protein, haemoglobin A1c, triglycerides and cholesterol 2. Body height (cm) and body weight (kg) collected to analyse body mass index (BMI) 3. Diastolic and systolic blood pressure (mmHg) measured with an automated blood pressure monitor. A body tape measure will be used to measure hip to waist ratio 4. Self-reported physical activity measured using IPAQ-short form (Ingledew and Markland., 2008) 5. Planning and coping planning of behaviour change measured using self-reported questionnaire adapted from Sniehotta, Scholz and Schwarzer., 2003 6. Behaviour regulations in exercise measured using BREQ-2 (Markland and Tobin 2004) 7. Quality of life measured using EQ-5D-5L (Herdman et al., 2011) 8. General self-efficacy measured using self-reported questionnaire from Jerusalem and Schwarzer 1979 9. Self-esteem measured using self-reported questionnaire from Rosenberg, 1986 10. Perceived and received social support assessed through questionnaires adapted from previous research (Freeman and Rees., 2008)	—

Measure

Time frame

Measured at baseline, immediately post intervention, and 6 and 12 months post intervention: 1. Fasting measures of plasma, serum or whole blood insulin, glucose, non-esterfied fatty acids, interleukin-6, tumour necrosis factor alpha, C-reactive protein, haemoglobin A1c, triglycerides and cholesterol 2. Body height (cm) and body weight (kg) collected to analyse body mass index (BMI) 3. Diastolic and systolic blood pressure (mmHg) measured with an automated blood pressure monitor. A body tape measure will be used to measure hip to waist ratio 4. Self-reported physical activity measured using IPAQ-short form (Ingledew and Markland., 2008) 5. Planning and coping planning of behaviour change measured using self-reported questionnaire adapted from Sniehotta, Scholz and Schwarzer., 2003 6. Behaviour regulations in exercise measured using BREQ-2 (Markland and Tobin 2004) 7. Quality of life measured using EQ-5D-5L (Herdman et al., 2011) 8. General self-efficacy measured using self-reported questionnaire from Jerusalem and Schwarzer 1979 9. Self-esteem measured using self-reported questionnaire from Rosenberg, 1986 10. Perceived and received social support assessed through questionnaires adapted from previous research (Freeman and Rees., 2008)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026