Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

What this study found

Primary outcome: weight change over 6 months did not differ significantly among regimens (Standard Care: −1.2 kg; In-person: −0.1 kg; mHealth: −0.2 kg; p>0.4 for between-group comparisons). At 3 months, calories as a percent of calculated needs increased by 0% (Standard Care), 6.8% (In-person), and 12.2% (mHealth); mHealth vs Standard Care approached significance (p=0.06). PROMIS QOL at 3 months improved by +0.3 units in mHealth vs −2.1 in Standard Care (p=0.09); by 6 months, all groups declined or worsened with no significant between-group differences. ALSFRS-R decline over 6 months tended…

Study & population

Randomized, open-label, standard-of-care-controlled, single-center clinical trial at Massachusetts General Hospital ALS clinic; 80 adults with ALS randomized to one of three nutritional counseling regimens.

Intervention

Nutritional counseling regimens over 6 months delivering tailored caloric goals to maintain/increase body weight: (1) standard care with general nutrition counseling by physician or nurse; (2) in-person counseling by a registered dietitian with monthly personalized dietary goals; (3) mHealth-supported counseling by a…

Key limitation

Single-center, small sample (n=80); open-label design with potential contamination; incomplete retention (11% at 3 months, 27% at 6 months); not powered to detect weight differences; adherence varied and some data were missing; baseline sex distribution differed by group; generalizability limited.

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