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Feasibility, Acceptability, and Cost-Effectiveness of an Acceptance and Commitment Therapy-Based Dietary Intervention on Weight Management and Psychosocial Outcomes in Adults with Overweight and Obesity: the protocol for a cluster-randomized trial in the primary healthcare setting

Feasibility, Acceptability, and Cost-Effectiveness of an Acceptance and Commitment Therapy-Based Dietary Intervention on Weight Management and Psychosocial Outcomes in Adults with Overweight and Obesity: the protocol for a cluster-randomized trial in the primary healthcare setting

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170812035642N8
Enrollment
130
Registered
2025-09-29
Start date
2025-10-06
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Overweight and Obesity. Overweight and obesity

Interventions

Intervention 1: Intervention group: Individuals in this group receive three interventions: Weight Loss Diet, Acceptance and Commitment Behavioral Therapy intervention, and Physical Activity interventi
Session 1: Getting to know and building relationships with group members, psycho-education, understanding cognitive fusion, mindfulness, and emotion from an ACT perspective, and distributing a questio
Session 2: Discussing experiences and evaluating them, creating creative frustration, asking individuals to talk about their anxieties, and reviewing the effectiveness of the next week's practice
Session 3: Introducing the desire to experience emotion as an alternative to control, the degree of apparent success in controlling emotions, programming internal events, and practicing numbers
Session 4: Review of previous session experiences, behavioral task and commitment, introduction of fault-finding, application of cognitive fault-finding techniques, rest and reception, intervention in
Session 5: Review of observer's task and behavioral commitment, showing the separation between self, inner experiences and behavior, observing self as a context, weakening self-concept and self-expres
Session 6: Performance assessment, application of mindfulness methods, conflict between experience and mind, rest and receptio

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 59 Years

Inclusion criteria

Inclusion criteria: Aged 20–59 years. Body Mass Index (BMI) between 25.0 and 40.0 kg/m² Express willingness to engage in the program Be a current resident of Tehran

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Currently following a specialized or prescribed diet Diagnosis of diabetes, cancer, Alzheimer’s disease, Parkinson’s disease, or other chronic conditions that could interfere with the study Current use of anti-obesity medications History of bariatric surgery Current use of blood sugar-lowering drugs Employment as a night shift worker Any physical impairment preventing moderate physical activity Current substance abuse Diagnosis of depression and/or current use of antidepressant medication

Design outcomes

Primary

MeasureTime frame
Body Weight. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Digital scale.—

Secondary

MeasureTime frame
Body Mass Index. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Wall Height Gauge and Digital Scale.;Waist Circumference. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Tape Measure.;Waist-to-Hip Ratio. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Tape Measure.;Waist-to-Height Ratio. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Tape Measure and Wall Height Gauge.;Physical Activity. Timepoint: Beginning of the Intervention (Before the Start of the Intervention), mid-intervention, and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Physical Activity Log (Bouchard Activity Diary).;Feasibility. Timepoint: Throughout the study period, including enrollment, mid-intervention follow-ups, and post-intervention assessment. Method of measurement: Evaluating recruitment rate, eligibility rate, study enrollment, dropout rate, dietary adherence, session attendance, completion of food diaries, adverse events, treatment satisfaction, and completeness of follow-up data.;Acceptability. Timepoint: During the intervention period and at post-intervention assessment. Method of measurement: A mixed-methods approach combining quantitative questionnaires and qualitative interviews with participants and data collectors to evaluate the suitability, satisfaction, and attractiveness of the intervention.;Cost-Effectiveness. Timepoint: Over the 3-month follow-up period, including monthly cost data collection and QALY assessment at baselin—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSakineh Shabbidar

Tehran University of Medical Sciences

s_shabbidar@tums.ac.ir+98 21 8895 5742

Outcome results

None listed

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