AWM: New Technology and Telenutrition (2013)

Citation:

Harvey-Berino J, Pintauro SJ, Gold EC. The feasibility of using Internet support for the maintenance of weight loss. Behav Modif. 2002; 26(1): 103-116.
 

PubMed ID: 11799651
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To assess the feasibility and acceptability of conducting a weight maintenance program over the Internet.

Inclusion Criteria:
  • At least 18 years of age
  • 30 pounds or more above ideal body weight
  • Free of major medical problems and not taking prescription medications
  • Provided written informed consent.
Exclusion Criteria:

Participants who did not have access to the Internet.

Description of Study Protocol:

Recruitment

Subjects were recruited for the study from newspaper advertisements.

Design

Randomized controlled trial.

Blinding Used 

Implied with measurements.

Intervention

  • Subjects initially took part in a 15-week behavioral weight control program and were then randomized to one of three maintenance conditions:
    • In-person, therapist-led (TL)
    • Internet, therapist-led (I)
    • Control (C).
  • Both maintenance interventions met biweekly for 22 weeks using the same program content
  • The therapist lead group met in person biweekly for 22 weeks. Participants turned in their self-monitoring diaries, were weighed and participated in a discussion facilitated by the group therapist. During weeks where in-person meetings were not held, subjects received a phone call from the group therapist and had the opportunity to submit their self-monitoring data, subjects also took part in a social influence peer support program.
  • Participants in the Internet group attended biweekly meetings in the form of an Internet chat session. Subjects entered the chat room at a prearranged time and the discussion was facilitated by a group therapist. During the weeks where Internet sessions were not held, participants received an e-mail from the therapist and had the opportunity to enter their weekly self-monitoring data on a Web Site form.
  • Group therapists were the researchers; one was a registered dietitian.
Data Collection Summary:

Timing of Measurements

Measurements made at baseline and after 22 weeks.

Dependent Variables

  • Weight was measured on a balance-beam scale with participants wearing their street clothes and height was self-reported
  • Both body mass index (BMI in kg per m2) and absolute weight were used as measures of obesity
  • Feasibility of conducting a program over the Internet was assessed by keeping recruitment records to determine the number of people screened out for not having appropriate computer hardware and access to the Internet
  • Further measures of acceptability and adherence to behavior change were used such as attendance at maintenance group sessions, adherence to self-monitoring goals, energy and total fat intake by three-day food records, the use of the Paffenberger Activity questionnaire to assess calories expended, peer support and acceptability of both maintenance conditions assessed at week 18 by having participants complete a five-item questionnaire that measured their perceptions with regard to the I or TL conditions.

Independent Variables

  • Subjects initially took part in a 15-week behavioral weight control program and were then randomized to one of three maintenance conditions:
    • In-person, therapist-led (TL)
    • Internet, therapist-led (I)
    • Control (C).
  • Both maintenance interventions met biweekly for 22 weeks using the same program content
  • The therapist lead group met in person biweekly for 22 weeks. Participants turned in their self-monitoring diaries, were weighed and participated in a discussion facilitated by the group therapist. During weeks where in-person meeting were not held, subjects received a phone call from the group therapist and had the opportunity to submit their self-monitoring data, subjects also took part in a social influence peer support program.
  • Participants in the Internet group attended biweekly meetings in the form of an Internet chat session. Subjects entered the chat room at a pre-arranged time and the discussion was facilitated by a group therapist. During the weeks where Internet sessions were not held, participants received an e-mail from the therapist and had the opportunity to enter their weekly self-monitoring data on a Web Site form.
  • Group therapists were the researchers; one was a registered dietitian.
Description of Actual Data Sample:
  • Initial N: 94 men and women expressed interest and 46 (nine men, 37 women) were randomized
  • Attrition (final N): Two participants (4%) dropped out during treatment; 90% completed the Week 15 assessment and 93% completed the Week 37 assessment.The number of participants with complete data was 41 (89%). 11 were in the therapist-led group and 12 were in the Internet group.
  • Age: Range 31 to 60 years, mean 46.3±7.4 years
  • Ethnicity: Predominantly white
  • Other relevant demographics: 95.6% employed full-time
  • Anthropometrics: Groups were similar at baseline
  • Location: Vermont.
Summary of Results:

Key Findings

  • Results showed that TL participants were more likely to attend their meetings and feel more satisfied with their group assignment (58%±22% vs. 33%±23%, P<0.005)
  • There were no differences between the TL and I groups in overall attrition or number of peer support contacts made
  • There was also no significant differences between the groups in weight loss, BMI, diet or exercise change during the maintenance conditions (-19.8±17.2, -15.5±23.4, -17.3±15.3, P=0.83 for TL, I and C, respectively).

 

Author Conclusion:

The Internet may hold promise as a method for maintaining contact with patients to facilitate long-term behavior change.

Funding Source:
Government: USDA Hatch Act Funds (HA-516)
University/Hospital: Office of Patient Oriented Research at Fletcher Allen Health Care
Reviewer Comments:
  • Small numbers of subjects in groups.
  • Methodology for statistical analysis not reported.
  • The authors noted that the limited sample size and maintenance program length prohibits drawing conclusions with regard to the effectiveness of the Internet for sustaining behavior change.
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? No
2. Was the selection of study subjects/patients free from bias? No
  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? No
  2.4. Were the subjects/patients a representative sample of the relevant population? No
  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.) Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  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? No
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  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)? No
  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)? No
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
  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? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes
  10.2. Was the study free from apparent conflict of interest? Yes