EAL

MNT: Weight Management (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare weight regain, satisfaction and convenience among three weight maintenance programs: telehealth, traditional classes and no program.

Inclusion Criteria:

Men and women older than 18 years of age
Participation in a 24-week community-based weight loss program (Colorado Weigh)
Minimum 7% weight loss before enrollment.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Subjects were successful weight losers who all lost weight in the same behavioral weight-loss program: Colorado Weigh. Subjects were assigned to groups based on their choice.

Design

Quasi-experimental; non-randomized controlled trial

Blinding used

Implied with measurements

Intervention

Telehealth participants interacted with a registered dietitian (RD) through the Web and e-mail (Colorado Weigh High-Tech). Participants interacted online with the RD every other week for 24 weeks. Individuals used computer software to record dietary intake and activity and complete a Health Report every other week. The RD focused on each individual's goals to provide personalized feedback and encouragement.
Traditional program participants attended a traditional classroom program (Colorado Weigh Graduate Program). Participants attended class every other week for 24 weeks and continued to track their calories, fat grams, and activity using paper logs. An RD led the group classes and offered support and counseling. Group leaders were RDs who presented an overview of the week's topic, led the group discussion, and provided support and feedback to participants based on reported food intake and physical activity during the previous two weeks.
Participants in the no-program group received no interaction, no materials or support, but were asked to return to the clinic at three and six months for a follow-up assessment.

Statistical Analysis

Final sample size of 21 subjects per group was needed to detect a clinically meaningful difference in weight change between groups with 80% power. Assuming a 30% dropout rate, the goal was to recruit 30 subjects into each group.
Repeated measures ANOVA was used to compare weights at baseline and six months among all groups, and 95% confidence intervals were calculated for weight regain for each group.
Combined convenience and satisfaction scores were compared between the traditional group and telehealth group using one-way ANOVA.
Results were analyzed using Last-Observation-Carried-Forward analysis.

Data Collection Summary:

Timing of Measurements

All participants were followed up for six months. Body weight was measured at baseline and three and six months. Program satisfaction and convenience was assessed at the end of the study.

Dependent Variables

Weight measured on Tanita digital scale under fasting conditions, wearing light indoor clothing without shoes
Height measured using standard stadiometer
Satisfaction and convenience assessed through self-administered survey instrument.

Independent Variables

Choice of Colorado Weigh Graduate Program (traditional classroom setting), Colorado Weigh High-Tech (telehealth setting), or no program.

Control Variables

Description of Actual Data Sample:

Initial N: 87 enrolled in the study (14 men and 73 women): 31 in the traditional classroom group, 31 in the telehealth group and 25 in the no-program group

Attrition (final N): 75 completed the study (86%), 24 in the traditional classroom group, 27 in the telehealth group and 24 in no-program group. There were no systematic differences between the total dropouts and dropouts in each group.

Age: Mean age, 50±9.3 years (range, 24-73 years)

Ethnicity: 93% white

Other relevant demographics: 87% had completed education beyond high school

Anthropometrics: Height, 1.68±0.09 m; Weight, 80.5±18.4 kg, with no significant differences among groups

Location: Colorado.

Summary of Results:

Key Findings

Over six months, the traditional group lost 0.5±4.3 kg, the telehealth group lost 0.6±2.5 kg and the no-program group gained 1.7±3.0 kg.
Weight change among all three groups was significant (P=0.02) and subjects in the no-program group gained significantly more weight than the telehealth and traditional groups.
The mean difference in weight change between the telehealth and Colorado Weigh Graduate Program was not significant (0.10 kg, P=0.92).
There were no differences in overall satisfaction between the telehealth and traditional groups (P=0.043), but individuals in the telehealth group rated their program as more convenient compared with those in the traditional group (P=0.0001).
The time required by the RD over the six months was similar for both programs: 2.4 hours per person for the telehealth program and 2.5 hours per person for the traditional program. Additional materials cost $33 per person ($3 for notebook/educational materials, $30 for software) for the telehealth program and $18 per person ($3 for notebook/educational materials, $8 calorie/fat counter book, $2 paper logs, $5 pedometer) for the traditional program, leading to a difference of $12.50 per person between programs ($93.00 per person for the telehealth program and $80.50 per person for the traditional program).

Weight Change Between Groups

Variables	Traditional program (n=31)	Telehealth program (n=31)	No program (n=25)
Baseline weight (kg)	85.5±20.6	80.1±19.1	74.9±12.8
Six-month weight (kg)	85.0±19.6	79.5±19	76.5±13.1
Weight change (kg)	-0.5±4.3	-0.6±2.5	+1.7±3.0

Author Conclusion:

In summary, these results showed the potential usefulness of telehealth programs in long-term weight-loss maintenance. As a starting point, they might be a useful alternative for those who successfully lose weight in a structured behavioral program but do not have the availability of or do not choose to participate in a formal behavioral weight-loss maintenance program.

Funding Source:

Government:

NIH R37 Research Grant (DK042549)

Reviewer Comments:

86% dropout rate. Authors note the following limitations:

This was not a randomized study
Participants selected their treatment
This was a highly educated group with high levels of Internet access; the telehealth option may not be effective for all subjects.

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?		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.)	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
	3.5.	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%.)	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
	4.5.	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?	Yes
	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
	6.4.	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?	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?	???
	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)?	???
	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
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