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MNT: Weight Management (2015)

Citation:

Morrison Z, Douglas A, Bhopal R, Sheikh A, Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of south Asians at high risk of diabetes. BMJ Open. 2014; 4: e004736.

PubMed ID: 24951108
 
Study Design:
Descriptive Study
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To obtain a rich and multi-faceted understanding of reasons for trial participation and retention and factors influencing lifestyle intervention to give insight into the social and behavioral dimensions of the trial method and results.
Inclusion Criteria:
  • This study used participants from a main trial for which the inclusion criteria are described elsewhere
  • Inclusion criteria for this study include:
    • Attendance at final trial visit
    • Written consent.
Exclusion Criteria:
This study used participants from a main trial for which the exclusion criteria are described elsewhere.
Description of Study Protocol:

Recruitment

  • Recruitment details for main trial are discussed elsewhere
  • Participants for this trial were recruited at the last trial visit by a dietitian.

Design

  • Qualitative study to inform understanding of patient experiences of the trial processes
  • A selection of participants was made utilizing the purposeful sampling strategy and contacted to arrange a research meeting
  • All interviews were conducted a location and in the language of the participants' choice with interpreter services used as needed
  • The researcher was blinded to the performance of trial participants throughout the course of the research process
  • Narrative-based interviewing methods were used to gather participants' accounts of their experiences
  • Thematic data analysis was concurrently undertaken using NVivio9 software, allowing emerging themes to inform ongoing data collection using the constant comparison method
  • Active consideration of alternative explanation cases and allowing researcher's reflexive analysis of interpretations, combined with regular discussions of emerging findings and active seeking of disconfirming data further ensured the trustworthiness of findings
  • Data collection ended when saturation could reasonably be assumed.

Blinding Used
Researchers were blinded to the performance of trial participants throughout the course of the research process.

Intervention
Dietitian-delivered lifestyle modification.

Statistical Analysis
None.

Data Collection Summary:

Timing of Measurements
Narrative interviews were conducted once.

Variables

  • Geographical location
  • Study intervention
  • Ethnicity
  • Language
  • Faith
  • Gender
  • Perspectives on potential benefits of participation
  • Participant choice 
  • Relationships with research team
  • Reasons for adherence
  • Reasons for non-adherence.
Description of Actual Data Sample:
  • Initial N: 25 interviews scheduled
  • Attrition: 21 interviews conducted (20 research participants and 4 family members)
  • Age: Not described
  • Ethnicity (self-defined): Nine Indian and 11 Pakistani.

Other Relevant Demographics

13 males and 11 females (trial participants and family volunteers)
 
  Preferred Language Faith
English Urdu Punjabi >1 language Use of interpreter None Muslim Sikh
Male 9 0 0 3 3 1 6 5
Female 3 2 1 2 4 0 4 4
Total 12 2 1 5 7 1 11 9

Anthropometrics
Not described.

Location
Scotland.

Summary of Results:

Key Findings

Participation and retention in trial
  • No significant points of differentiation between the Intervention and Control Group participants
  • Perceived benefits of participation in trial, accommodation of participant choice of language and location and trusting relationships between trial investigators and participants contributed to high retention rate.
Adherence to intervention
  • Adherence involved different understandings of the advocated lifestyle changes and unanticipated motivations such as caring for other family members or a sense of obligation to the dietitian
  • Non-adherence to the trial was in some cases culturally motivated or due to contextual factors such as climate or lack of time.
Author Conclusion:
Although participants had a strong personal interests in participation and found the information provided by dietitians useful, they also struggled to incorporate the dietary and exercise recommendations into their daily lives.
Funding Source:
Government: National Prevention Research Initiative , NHS Lothian and NHS Greater Glasgow and Clyde R&D, Chief Scientist Office, NHS Scotland and NHS National Services Scotland
Reviewer Comments:
Use of interpreters, as needed, for data generation was a study limitation.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? No
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? N/A
  8.2. Were correct statistical tests used and assumptions of test not violated? N/A
  8.3. Were statistics reported with levels of significance and/or confidence intervals? N/A
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes