NC: Maintenance of Health/Behavior Change Following Short-term CBT (2008)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To identify baseline correlates of 16-month weight loss in previously overweight and obese women who participated in a four-month behavioral weight management program.

Inclusion Criteria:
  • Age: 40 to 55 years
  • Body Mass Index (BMI): 25 to 38kg per m2
  • Non-smoker
  • Free from major illness.
Exclusion Criteria:

None specified.

Description of Study Protocol:

Recruitment

Newspaper and TV advertisements.

Design

Retrospective cohort study.

Blinding Used

None.

Intervention

  • Group meetings, one time per week, 150 minutes per session
  • About 25 subjects per group
  • Progressive changes in lifestyle (eating habits and physical activity), leading to a moderate daily energy deficit (less 300 to 500kcal per day)
  • Target weight loss: 0.5kg per week
  • Individualized goals for energy intake and expenditure were provided to all subjects
  • Cognitive and behavioral strategies used to improve compliance
    • Self-monitoring
    • Self-efficacy enhancement
    • Cognitive restructuring
    • Relapse prevention and problem-solving skills
    • Stress management
    • Preventing emotional eating
    • Social support. 

Statistical Analysis

  • Psychometric variables: Spearman rank order correlation (since a majority displayed a significantly skewed distribution)
  • Comparisons of baseline data between completers and non-completers; comparisons of subjects in different success categories: Independent sample T-tests and analysis of covariance (ANCOVA)
  • Weight changes analyzed for completers only and additionally by two procedures employed to include baseline data for all starting subjects, following an intent-to-treat model: 
    • Baseline observation carried forward (BOCF) (all dropped subjects were assumed to have returned to baseline weight by 16 months)
    • A modified version of the last observation carried forward method (LOCF+)
  • The last measured weight was used as the final weight with 0.2kg added per each month passed since the last laboratory assessment
  • Predict group classification at 16 months based on pre-treatment variables: Logistic regression with backward stepwise selection 
  • P-value of 0.157 and 0.05 was selected for removal of predictors
  • Models chosen maximized overall classification scores while also resulting in the most parsimonious events per variable ratio (an event defined as the number of positive or negative cases in the outcome variable, whichever is lower, 43 and 57, respectively, for non-completion and weight loss success)
  • Ten or more events per independent variable, corresponding (in this study) to a maximum of four or five predictors per model, is considered adequate.     
Data Collection Summary:

Timing of Measurements

  • Pre-treatment
  • Four months (end of intervention)
  • 16 months.

Dependent Variables

  • Attrition
  • Weight
  • Used to define two categories of success, based on 16-month weight data: 
    • Successful participants (lost less than 5% initial body weight) 
    • Non-successful participants: Those showing no weight  loss or weight gain (weight change ±-0.5kg) at 16 months
  • Body composition: Dual energy X-ray absorptiometry (DXA, Lunar DPX-IQ software version 4.6)
  • Additional success category: Those losing 10% or more of initial fat mass, regardless of weight change.

Independent Variables

  • Physical activity minutes per day and energy expenditure (kJ per day) from leisure-time moderate and vigorous physical activities (i.e., activities with METs greater than 3.8): Seven-Day Physical Activity Recall (Sallis et al, 1985)
  • Dietary intake: Three-day food records averaged from one weekend and two week days
  • Dieting/weight history: Study-specific questionnaire
  • Weight outcome evaluations: Goals and Relative Weights Questionnaire
  • Quality of Life: General SF-36; Obesity-specific Impact of Weight on Quality of Life-lite)
  • General social support: Five items originally developed for the Medical Outcomes Study (MOS)
  • Depressive symptoms: Beck Depression Inventory
  • Self-esteem: Rosenberg's Self-esteem/Self-concept questionnaire
  • Self-motivation: Self-Motivation Inventory
  • Eating behavior variables: Binge Eating Scale; Eating Self-Efficacy Scale and Eating Inventory
  • Cognitive restraint, eating disinhibition, and perceived hunger: Eating Inventory
  • Self-efficacy for exercise: Self-Efficacy for Exercise Behaviors Scale (measures beliefs that a person can 'stick with' an exercise program for at least six months under varying circumstances; two sub-scales= 'resisting relapse; and making time' 
  • Exercise perceived barriers: Exercise Perceived Barriers scale; included two of three sub-scales: 'Time' (three items) and 'effort' (six items) averaged to produce a total exercise barriers score
  • Exercise social support: 10 items from Exercise Social Support questionnaire (developed to assess participation and involvement from family and friends with regard to one's exercise)
  • Body image:
    • Body Shape Questionnaire (measures concerns with body shape and 'feeling fat')
    • Body Image Assessment Questionnaire (self-ideal difference)
    • Body Cathexis Questionnaire (assess feeling towards various body parts or characteristics).

Control Variables

None.

 

Description of Actual Data Sample:
  • Initial N: 158 women
  • Attrition (final N):
    • End of four-month treatment: N=136 (14% attrition)
    • End of 16-month follow-up: N=111 (30% attrition)
  • Age: 48.0±4.5 years
  • Ethnicity: Not stated
  • Other Relevant Demographics: None
  • Anthropometrics:
    • Total sample
      • BMI: 31.0±3.8kg per m2
      • Body fat: 44.5±5.3%
    • Completers (N=111)
      • Weight: 83.2kg
      • BMI: 30.4kg per m2
      • Body fat: 44.0%
      • Waist to hip ratio: 0.82
    • Non-completers (N=47)
      • Weight: 87.9kg*
      • BMI: 32.7kg per m2 ***
      • Body fat: 45.9%*
      • Waist to hip ratio: 0.83
      • Difference compared to completers: * P<0.05;  *** P<0.001
  • Location: University of Arizona, Tucson, Arizona. 
Summary of Results:

 Weight Loss (kg)

Group

Four Months  (Percentage Change)

16 Months  (Percentage Change)

Completers

  -5.1 (-6.2%); N=136

  -4.6 (5.5%); N=111

BOCF  

   -3.2 (-3.9%); N=158

LOCF+  

 -3.0 (-3.7%); N=158

Successful  

 -9.5 (-11.5%); N=53

Non-successful (BOCF)  

  +0.8 (+1.0%); N=71

Non-successful (LOCF+)  

  +1.3 (+1.5%); N=71

Successful (Body Composition Adjusted)  

   -8.4 (-10.2%); N=63

  • Average weight loss after four months (N=136 completers) 5.1kg (-6.2% initial weight)
  • Average weight loss at 16 months (N=111) 4.6kg (-5.5% initial weight), while mean change for all participants (N=158) was in the range of -3.2 (-3.9%) to -3.0kg (-3.7%).

COMPLETION VS. NON-COMPLETION

Significant Differences between Non-completers and Completers at Baseline

Completers vs. non-completers

  • Weighed less (83.2kg) than completers (87.9kg); P<0.05
  • Were more active (20.8 vs. 14.3 minutes per day); P<0.05
  • Reported consuming more calories (100.5 vs. 90.8; P<0.05); higher dietary carbohydrate (2.96 vs. 2.5g per kg per day; P<0.01) and higher amounts of fiber (19.5 vs. 16g per day; P<0.01)
  • Had dieted significantly less often in the previous year (1.76 vs. 3.28); P<0.001
  • Had weight fluctuated fewer times during adulthood 1.71 vs. 2.01 frequency of weight  change ±4.5kg; P<0.05
  • Reported lower levels of binge eating (16.64 vs.13.22); P<0.01
  • Displayed more accepting evaluations with regard to weight loss including: A lower accepting dream weight (75.2% vs. 69.9% of initial weight; P<0.01)  
  • Had more positive scores for quality of life: (SF-36 physical: 83.7 vs. 78.1; P<0.05; SF-36 mental: 77.2 vs. 70.2; P<0.05; weight-specific QOL: 79.3 vs. 69.0; P<0.001)
  • Showed better psychological health: (Depression 9.76 vs. 12.99; P<0.01; self-esteem: 8.59 vs. 7.90; P<0.05) 
  • Displayed fewer body image problems: (Body shape concerns: 102.3 vs. 116.6; P<0.01; body size dissatisfaction: 3.26 vs. 3.74; P<0.05; body cathexis: 3.20 vs. 2.88; P<0.001)
  • When analyses were replicated adjusting for baseline weight or BMI using ANCOVA, results were unchanged
  • Differences between completers (N=111) and non-completers (N=47) for weight-related quality of life (WQOL-lite) and exercise dimensions:
    • Weight-related quality of life: Completers (vs. non-completers) had significantly higher scores on physical functioning (75.7 vs. 68.9; P<0.05); self-esteem (67.2 vs. 56.4; P<0.01); sexual life (75.0 vs. 60.6; P<0.01); public distress (89.0 vs. 82.0; P<0.05) and work (89.7 vs. 78.5; P<0.001)
    • Exercise: There were no significant differences on any exercise dimension between completers and non-completers.

Variables predicting weight change:

  • Few variables predicted weight change when only completers were analyzed
  • In intent-to-treat models that included drop-outs, pre-treatment measures associated with weight loss included:
  • Negative predictors: Abdominal fat distribution, more frequent previous dieting, more stringent weight loss evaluations, and exercise perceived barriers
  • Positive predictors: Weight specific quality of life, self-motivation, eating and exercise self-efficacy and a better body image

Prediction of Completion vs. Non-completion

  • Best model for program completion included baseline carbohydrate intake (B=0.62; P=0.026), the number of previous diets (B=-0.23; P=0.012), 'happy' weight loss evaluations (B=0.12; P=0.001) and quality of life (B=0.04; P=0.004)
  • Model was highly sensitive to program completion, predicting completion in 107 of 111. However, it wrongly classified 20/44 (45%) of non-completers as completers (Chi Square 45.5; P<0.001). It correctly classified 84.2% of subjects as completers.

SUCCESSFUL VS. NOT SUCCESSFUL

Differences at baseline between groups using success criterion based only on body weight (and BOCF)

Compared to those classified as unsuccessful, successful participants had (values not given):

  • Lower waist to hip ratio (P=0.027)
  • Higher reported dietary carbohydrate intake (g per kg per day) (P=0.027)
  • Had higher reported total fiber consumption (P=0.027)
  • Lower number of diets in previous year (P=0.002)
  • Higher "dream" weight (percentage of initial) (P<0.001)
  • Higher "happy" weight (percentage of initial) (P<0.001)
  • Higher weight-specific QOL (P=0.006)
  • Fewer exercise perceived barriers (P=0.035)
  • Higher exercise self-efficacy (P=0.031)
  • Reported more minutes of exercise (P=0.05)
  • Higher body cathexis (P=0.006)
  • Had a poorer body image as indicated by a greater self-ideal difference in the Body Image Assessment Questionnaire (P=0.026)
  • Comparing success category adjusted for body composition showed that the differences between the same variables were significant
  • Differences between successful (N=53) and non-successful (N=71) groups on weight-related quality of life (WQOL-lite) and exercise dimensions:
    • Weight-related quality of life: Successful (vs. non-successful) participants had higher scores on physical function (77.2 vs. 70.1; P<0.05); self-esteem (70.6 vs. 59.9; P<0.01); public distress (90.2 vs. 84.1; P<0.05); and work 90.0 vs. 82.4; P<0.05). Scores for sexual life dimension were NS.
    • Exercise: Successful (vs. non-successful) participants had lower score on effort (perceived barriers) (2.78 vs. 3.08; P<0.05) and higher resisting relapse-self-efficacy scores (4.10 vs. 3.83; P<0.05).

Prediction of Success at 16 months

  • Final model predicting weight loss success included waist-to-hip ratio (B=-7.77; P=0.024), number of previous diets (B=-0.29; P=0.012); 'happy' weight loss evaluations (B=0.12; P=0.002) and exercise self-efficacy (B=1.00; P=0.012)
  • The model correctly predicted weight loss category for 68%, while the percent of participants wrongly predicted as non-successful was 11% (Chi Square 33.6; P<0.001). The model correctly classified 74.0% of subjects as successful.

 

 

Author Conclusion:
  • Psychosocial and behavioral variables may be useful as pre-treatment predictors of success level or attrition in previously overweight and mildly obese women who volunteer for behavioral weight control programs. These include dieting history, dietary intake, outcome evaluations, exercise, self-efficacy and quality of life. 
  • These factors can be used in developing readiness profiles for weight management, a potentially important tool to address the issue of low success and completion rates in the current management of obesity.
Funding Source:
Reviewer Comments:
  • Numerous variables analyzed, increasing possibility of type 1 error. Although authors acknowledge this, it is not adjusted in analysis. 
  • Results are consistent with other studies.

 

 

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? N/A
  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? N/A
  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? ???
3. Were study groups comparable? Yes
  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? Yes
  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? Yes
  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? ???
  4.1. Were follow-up methods described and the same for all groups? ???
  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%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? ???
  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? N/A
  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.) N/A
  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? Yes
  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? Yes
  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? N/A
  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? Yes
  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? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  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)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  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