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AWM: New Technology and Telenutrition (2013)

Citation:

Harvey-Berino J, West D, Krukowski R, Prewitt E, Van Biervliet A, Ashikaga T, Skelly J. Internet delivered behavioral obesity treatment. Prev Med. 2010; 51 (2): 123-128.

PubMed ID: 20478333
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  • To evaluate the efficacy of an Internet behavioral weight loss program and determine if adding periodic in-person sessions to an Internet intervention improves weight loss outcomes
  • To evaluate the treatment adherence and perceived social support across the different treatment delivery modalities.
Inclusion Criteria:
  • Overweight with a body mass index between 25kg/m2 and 50kg/m2
  • Access to a computer with an Internet connection were recruited at two clinical centers
  • Provided written informed consent.
Exclusion Criteria:
  • History of major medical or psychiatric conditions
  • Changes in medication known to affect weight
  • Current, planned or recent pregnancy, medical conditions that would prohibit exercise
  • Schedule that would prohibit or restrict attendance at a designated time for weekly group meetings.
Description of Study Protocol:

Recruitment

  • Recruitment was conducted from February 2003 to March 2005
  • Interested participants were able to apply via a study recruitment website.

Design

Randomized controlled trial.

Blinding Used

Implied with measurements.

Intervention

Subjects were randomized to one of three delivery methods of a behavioral weight loss program with weekly meetings. Programs received identical behavioral lessons and individualized counselor feedback on progress towards meeting exercise and dietary intake goals. Group counselors used a written protocol that outlined standard lessons with counselor guides to ensure comparability of intervention methods. Counselors included behaviorally trained graduate students, clinical psychologists and registered dietitians with extensive weight management experience and were cross-trained such that they were able to deliver the intervention across modalities.

  • Internet conditions: Participants in the Internet condition met weekly in small groups of 15 to 20 individuals in a secure online chat room. They were asked to review the week's session materials prior to the chat meeting with a new lesson every week. Participants had access to an online database to help monitor caloric intake.
  • Hybrid conditions: Participants in this condition had access to the same Internet treatment program but once a month they substituted an in-person group meeting for an online chat. Session materials were delivered electronically even in weeks when they met in-person.
  • In-person conditions: Subjects were weighed by study staff prior to the beginning their group session which consisted of 15 to 20 subjects. Each week they received materials that covered the topic in that session. They were also provided a commercially available calorie and fat counting book.

Statistical Analysis

  • Intent-to-treat analysis was used to analyze weight loss with baseline value carried forward for individuals missing six month outcome data
  • Mixed models were used to compare treatment groups on baseline characteristics, adherence measures and baseline to six-month change in weight, physical activity and dietary outcomes
  • Mixed model analysis of variance was used to compare the treatment and site as fixed main effects wave within site as a random main effect and the associated interactions of the main effects
  • Dichotomous outcome measures was analyzed using the SAS Glimmix procedure with a binary distribution
  • All analyses were run using SAS V 9.1.
Data Collection Summary:

Timing of Measurements

Measurements made at baseline and six months.

Dependent Variables

  • Primary outcome was weight change: Weight was measured in street clothes and without shoes on a calibrated scale. Height was measured with a wall mounted stadiometer. BMI was calculated as kg/m2.
  • Secondary outcome was treatment adherence: Counselors recorded participant attendance at group sessions and self-monitoring journal submissions. Data on social support were collected at six months. The perceived social support scale was used to assess the level of support group members perceived from other members of their intervention group.
  • Dietary intake was measured with a self-report food frequency questionnaire, Block version 98.2 assessing usual intake over the previous six months
  • Daily energy intake and percent calories from fat were estimated using scoring algorithms performed by Nutrition Quest
  • The Paffenberger Physical Activity Questionnaire was used to estimate energy expended in physical activity.

Independent Variables

  • Internet conditions: Participants in the internet condition met weekly in small groups of 15 to 20 individuals in a secure online chat room. They were asked to review the week's session materials prior to the chat meeting with a new lesson every week. Participants had access to an online database to help monitor caloric intake.
  • Hybrid conditions: Participants in this condition had access to the same Internet treatment program but once a month they substituted an in-person group meeting for an online chat. Session materials were delivered electronically even in weeks when they met in person.
  • In-person conditions: Subjects were weighed by study staff prior to the beginning their group session which consisted of 15 to 20 subjects. Each week they received materials that covered the topic in that session. They were also provided a commercially available calorie and fat counting book.

 

Description of Actual Data Sample:
  • Initial N: 658 individuals provided informed consent and 481 men and women randomized to one of three groups
  • Attrition (final N): 462 subjects attended the six-month assessment (96%)
  • Age: Mean age 46.6±9.9 years
  • Anthropometrics: Mean BMI kg/m2 35.7±5.6. There were no significant differences between groups at baseline.
  • Location: Vermont and Arkansas.
Summary of Results:

Key Findings

  • Conditions differed significantly in mean weight loss 8.0kg±6.1kg vs. 5.5kg±5.6kg vs. 6.0kg±5.5kg, for In-Person, Internet and Hybrid respectively (P<0.01)
  • Weight loss for In-Person was significantly greater than the Internet and Hybrid conditions (P<0.05)
  • Although the proportion reaching a 5% weight loss did not differ, the proportion losing 7% did differ significantly (56.3% vs. 37.3% vs. 44.4% for In-Person, Internet and Hybrid, respectively (P<0.01).

 

 

 

Author Conclusion:

The results from this study demonstrate that the Internet is a viable alternative to in-person treatment for the delivery and dissemination of a behavioral weight control intervention. The addition of periodic in-person sessions did not improve outcomes.

Funding Source:
Other: No funding reported
Reviewer Comments:

This study did not include a no-treatment control group.

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
  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
  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
  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
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
  1. Was the research question clearly stated? Yes
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.1. 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
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
  1.3. Were the target population and setting specified? Yes
  2. Was the selection of study subjects/patients free from bias? 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
  2.1. 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
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? 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
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
  3. Were study groups comparable? Yes
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) Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  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
  3.3. 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
  3.4. 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
  3.5. 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
  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. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? 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%.) 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%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? 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. 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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  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
  5.2. 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
  5.3. 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
  5.4. 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
  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. 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
  6.1. 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? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? 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
  6.4. 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? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? Yes
  6.6. Were extra or unplanned treatments described? Yes
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  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
  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. 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
  7.1. 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
  7.2. 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
  7.3. 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
  7.4. 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
  7.5. 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
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? 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. 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
  8.1. 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
  8.2. 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
  8.3. 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
  8.4. 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
  8.5. 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
  8.6. 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? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? 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. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? No
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? Yes
  10.2. Was the study free from apparent conflict of interest? Yes